Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

A positive bias in PSA results may impact clinical interpretations of test results. In cases where true values ​​are close to cut, bias may increase the likelihood of a decision to initiate complementary diagnostic tests (including prostate biopsy). The risk of unnecessary biopsy is mitigated by the fact that the physician / patient decision for prostate biopsy is based on a number of additional factors for the PSA outcome, including the patient's age, findings in digital rectal examinations, clinical signs and symptoms or comorbidities such as inflammation or prostate infection. Total PSA is used in conjunction with a digital rectal examination to assist in determining if the patient is at risk for prostate cancer. The combination of the test result and an abnormal DRE may lead to a prostate biopsy. Sequential testing and a substantial change in results between tests may also raise the suspicion that the patient may be at risk for prostate cancer. When used in conjunction with the IMMULITE free PSA assay, bias would also result in a potentially lower than expected rate. Decreased indices are associated with increased risk of prostate cancer and could probably influence biopsy decisions. Findings in the biopsy are independent of the positive bias and health risk does not extend beyond biopsy and anxiety to the patient. The frequency of events of an increased value above the reference range of 4 is estimated at 5% (source not found) and having a positive DRE is estimated at 5% of the screened population equaling 2.5 x 10-3 in the worst case, very probably one tenth of this if the doctor questions the result. The health risk of an unnecessary biopsy is low.

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

According to the record holder, the new project includes the use of bar code for device recognition during clinical workflow and changes in the ERGO ++ TPS and MOSAIQ OIS systems to operate with the new functions. Check detailed information in the document IMPORTANT FIELD SAFETY NOTICE, available at http://portal.anvisa.gov.br/wps/wcm/connect/8dcb300040d173b29e01bf1b0133649b/Aviso_de_Seanca.pdf?MOD=AJPERES.

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

Dilution of the patient sample mainly serves to resolve results above the calibration range for hyperhomocytokineemic patients. Severe hyperhomocysteinemia may occur due to marked deficiencies of B-complex vitamins, or it may be associated with chronic renal failure. Rarely, severe hyperhomocysteinemia and hyperhomocysteinemia occur due to hereditary genetic defects such as cystathionine beta-synthase deficiency. Homocysteine ​​is used as an adjunct assay with direct measurement of specific B-complex vitamins or genetic test. In these cases, a negative bias in the dilution recovery result would have no impact on future treatment or mask a high value. As determination of homocysteine ​​levels is used as an aid in the diagnosis of a B-complex deficiency or hereditary deficiency, and treatment is based on the conditions of folic acid and vitamin B12 or genetic testing, it is not necessary to review the results of the samples that have previously been diluted 1:10, nor is it necessary to repeat the dilution tests of these patients. Thus, based on the research carried out, it was determined that there is no risk to health. Using a dilution of 1 to 10, a laboratory can achieve recovery from 60 to 70%, which will not impact the treatment options and will not mask a high value. Treatment is based on folic acid and vitamin B12 values ​​and / or genetic testing. Homocysteine ​​is typically an incidental finding and not a primary issue in diagnosis, so there is no risk to health.

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

The company reports that the event found may result in insufficient tissue apposition and may require surgical intervention to help achieve and maintain anastomotic integrity. To date, the company is not aware of any potential complications that have occurred as a result of this event

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

There is no Notification log in the NOTIVISA System.

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

See Alert Message. http://en.wikipedia.org/w/eng/index.php/

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

Investigative procedure of the Technovigilance Unit. PA 25351489988 / 2013-07.

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

The analysis identified that the severity is insignificant, because as the controls of the assay are out of range, adjustment will occur, preventing the release of patient results. There is no impact to patient samples when values ​​are not reported, so this action is classified as without health risk. Letter to the client: http://portal.anvisa.gov.br/wps/wcm/connect/6c0ba8804115b1d2aed3af0ea338d2ac/Carta_aos_clientes_+IMC_13_20.pdf?MOD=AJPERES

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

The company reports so far, there have been no reports of injury or adverse events in patients as a result of this defect. However, an interruption in the flow of irrigation fluid has the potential to cause overheating of the ablation tip and formation of a burn or thrombus, which in turn may present a thromboembolic risk to the patient./////24/11 / 2014 - The company announced the closure of this field action. According to the company all the customers were contacted, being collected 145 units of the product.

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

The production plant received 225 complaints related to the infusion rate greater than that intended, involving the elastomeric systems in question. According to the company, health care providers must continue to follow the instructions for use of the product to avoid the occurrence of changes in infusion rates - see attached details. #### UPDATED ON 08/18/2017, the field action documentations submitted by the company are filed in the area. If necessary, the area can reassess the action at any time.

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

The MRx may stop charging, defibrillating or stimulating, causing a delay in therapy. According to the manufacturer, you can continue to use the MRx before receiving the hardware upgrade, as long as you notice that if the MRx displays a red X on the RFU (ready-to-use) indicator during automated testing, a fault has been detected and can prevent the delivery of a shock or stimulation due to this problem. If this is found you should turn the Therapy button to Monitor. An INOP message describing the fault is displayed. If necessary, run an operational check for more information. If the condition persists, remove the device and call for service. Use a backup defibrillator in case an affected MRx does not deliver therapy.

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

According to information submitted by Terumo, a risk assessment was conducted and, based on this investigation, the management of Harvest Technologies Corp. (manufacturer) concluded that the following batches of GDP-10 were affected and should be collected: GDP-10-0046 , GDP-10-0047, GDP-10-0048, GDP-10-0050, GDP-10-0051, GDP-10-0052, GDP-10-0053, GDP-10-0054, GDP-10-0055, GDP -101-0010. Of these lots, only lot GDP-10-0048 was distributed in Brazil.

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

The product registration holder is sending a Safety Notice to its customers alerting the importance of meeting the preventive maintenance frequency of the Trilogy 100 Pulmonary Ventilator, as provided in the Equipment Manufacturer's Manual: preventive maintenance should be performed every two years or after 10,000 hours of use (whichever comes first) and the piece called "Blower" must be replaced preventively every 17,500 hours of use of the device. Sudden failure of the Blower during ventilation can lead to serious adverse events. The occurrence of adverse events related to the equipment must be notified to Anvisa through the NOTIVISA system, which can be accessed through the following link: http://www.anvisa.gov.br/hotsite/notivisa/index.htm.

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

Through the analysis of post-marketing surveillance data Edwards Lifesciences identified a potential health risk for patients undergoing bypass surgery when using an intravascular anastomotic shunt. Edwards received 23 complaints regarding high shunt adhesion that may interfere with bypass graft suture. In none of the 23 complaints was there any report of injury to the patient. Complaints were first reported in March 2013 for production lots manufactured as of June 2012. Based on this occurrence and potential impact on patients, Edwards is collecting the IVS Shunts models from the aforementioned lots that have not expired. Vascular shunts are designed to create an artificial passageway connecting two temporary main channels to the bloodstream distally at the surgical site, and to maintain blood flow in the cerebral vascular system. These shunts have a silicone body and balloons at the end and proximal end. The balloons are designed to provide shunt fixation in the vessel, with minimal arterial dissection and vessel wall trauma, and at the same time eliminates bleeding around the shunt during operative procedure. Nonconformity is associated with an excessive amount of silicone in Anastaflo Shunt, which can damage the blood vessel by removing the product before making the last stitch. If the overhang is not noticed prior to its use on the patient, it may damage the suture line and result in further surgical repair.

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

Baxter Hospitalar Ltda has detected increased leakage complaints between the lid and the luer of the product. Corrective actions were then implemented to improve the fence between the lid and the Luer, which solved the problem according to the company. To ensure that no affected products remain in circulation, they are being collected. Leakage of the lid and distal luer may result in delayed or interrupted therapy, which may result in administration of a lower dose to the patient and need for medical intervention. As a result of the problem, delays or interruptions of therapy may result in the administration of a lower dose to the patient and the need for medical intervention. The potential damage of delayed or discontinued therapy and exposure to hazardous substances is considered to be serious. In addition, patients and health professionals are potentially at risk of harm from exposure to hazardous solutions, such as chemotherapeutic agents. Access the Letter to Clients disclosed by the company at: http://portal.anvisa.gov.br/wps/wcm/connect/fe6d4b0041499b1b94329fa8d08ea2d4/Carta_ao_cliente.pdf?MOD=AJPERES. #### UPDATE: Infusion models under risk have been inserted in the "Product Description" field. According to Baxter, the product in question has more than 20 models of registered infusers, but this field action covers only two models. #### UPDATED ON 08/18/2017, the field action documentations submitted by the company are filed in the area. If necessary, the area can reassess the action at any time.

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

According to the manifestation of the company, there are no negative consequences of the use of the product considering the following points: 1) The product is used for monitoring glucose monitoring in neonates and not for diagnosis; 2) The substitution of contraindications for use in newborns by the recommendation of caution in the interpretation of blood glucose levels below 50mg / dl is in line with the current management guidelines for newborns with hypoglycemia, and is identical to that recommended in the use instruction equipment intended exclusively for use with this test strip; 3) The blood glucose values ​​obtained with the On Call Plus Test Strip meet international precision requirements, providing reliable readings that meet the hypoglycemic profile monitoring needs in neonates; 4) Before the product was registered in favor of Socinter, it was marketed under the registration of another company, with the same recommendation of caution in interpreting results in neonates below 50mg / dl; 5) Therefore, considering that the recommended use is what is in the current instruction of use and what is in the registry is what needs to be changed, there are no consequences that could compromise the health and safety of the neonate using the strips of On Call Plus glycemic test. UPDATE - 10/01/2014 - Attachment informative documents for the Hospital Client and the Hospital Distributor.

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

If the user does not detect the loss of resistance of the syringe due to the slip with greater resistance that the plunger may present, spinal anesthesia may occur instead of epidural anesthesia. If spinal anesthesia occurs, specific effects with a remote probability of occurrence include headaches and backaches, hypotension, urinary retention, and rare meningitis. Rare effects and unlikely occurrence include severe respiratory depression, hypotension, and decreased heart rate, which requires temporary advanced medical intervention with increased oxygen and administration of medications, or mechanical ventilation until the effects of anesthesia decrease. There are reports of cases in the literature without reports of studies with real incidence, presuming that these types of complications are very rare. In addition, the detection of specific and rarer effects should be part of the routine monitoring of patients receiving anesthesia.////// UPDATE 11/08/2014 - The company finalized the field action. An alert message was sent regarding the use of the product for customers and distributors.

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

The company is collecting batches at risk due to complaints received, related to obtaining false-positive results with the product in question. The retention samples in the manufacturer did not show the deviation, however the company is preventively collecting the product and is investigating the cause of the problem. Access to the Company Alert Message: http://portal.anvisa.gov.br/wps/wcm/connect/362e3b004152ff89a58fafa8d08ea2d4/Carta_de_Recall_aos_clientes.pdf?MOD=AJPERES

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

The product will be collected by the company. Precautions and warnings for using the EndoWrist Monopolar Curve Scissors until recoil is performed: (1) Do not apply power when the scissor tips are not in contact with tissue. Power should not be applied to an instrument when it is not in direct contact with the tissue (referred to as "shoot into the air"). Additionally, do not use an electrosurgical instrument to apply cauterization to any other instrument; (2) Be aware of critical anatomical elements in contact with the instrument during the activation of energy. While activating monopolar energy, be aware of anatomy elements that are in contact with the handle or stem of the instrument. The instrument shall not be used as a retractor during the application of energy; (3) Examine the surgical field. In the course of each surgical procedure, surgeons should examine the surgical field, especially where the distal end of the instrument stem may have been in contact with tissues. Also examine the tissues surrounding the main surgical field, including the "below" or "behind" areas of the cannula and the endoscope, which are normally out of sight; (4) Take into consideration the state of health of the patient. Before using monopolar cauterization in a surgical procedure, consider factors that may make elements of a patient's anatomy and tissues more susceptible to injury resulting from the application of cauterization (eg, patients who have received radiation therapy prior to surgery); (5) Use only one validated electrosurgical unit (SEU). ESUs that have been validated for use with EndoWrist monopolar instruments, including MCS, are listed in the Instrument and Accessories User Manual section 3.1; (6) Do not exceed the maximum settings for monopolar cauterization. The guidelines governing the maximum settings for cauterization are listed in section 3.3, ESU Definitions and Power Activation Cables in the Instrument and Accessories User's Guide. If the maximum settings for cauterization are exceeded, this will exceed the 3 kV limit of the instrument, which could result in arcing and thermal injury at other locations. The User's Manual also indicates that the user should set the power to the lowest value possible for adequate hemostasis. See general precautions and warnings in the Instruments and Accessories User Manual; (7) See general precautions and warnings in sections 2.1, 2.2, 4.1 and 4.2 of the Instrument and Accessories User's Manual.

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

Check for additional information in the Alert Message released by the product registration holder, available at http://portal.anvisa.gov.br/wps/wcm/connect/97107200415616e5ac03afa8d08ea2d4/Carta+Cliente.pdf?MOD=AJPERES.

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

Verify the details of the field action in the Medtronic Field Emergency Notification issued at Med.gov 08/27/2014: Field action completed by the company on 04/30/2014.

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

The company informs that there is no impact to the patient if the physician identifies the problem and removes the filter. If there is incorrect implantation of the product with the hook oriented in the cranial direction, it can result in severe injury or risk to the patient's life, including but not limited to dissection, vessel drilling, filter migration with secondary damage to cardiac structures and ineffective prevention of pulmonary embolism. The manufacturer Cordis carried out the root cause investigation and implemented corrective actions.

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

Image management software is a health product that can be registered with Anvisa and falls under the same equipment risk class, according to the provisions of Resolution RDC 185/2001 and Technical Note 04/2012 / GQUIP / GGTPS / ANVISA . The products described in this alert are free softwares, available in the public domain, used for the visualization and management of results of exams and diagnoses (DICOM files) obtained in procedures of radiography, tomography, magnetic resonance, among others. Since they have not been evaluated by the Agency in the pre-marketing stage, there is no guarantee as to the safety and efficacy of these products. In addition, there is no information available on representatives / distributors / technical assistance related to products in Brazil, which is an additional risk factor for their use. To consult the Technical Note n ° 04/2012 / GQUIP / GGTPS / ANVISA go to: http://portal.anvisa.gov.br/wps/wcm/connect/f96009004a70f3abb6f1f64600696f00/Note+T%C3%A9cnica+04_2012_GQUIP+Software+ MODULE = AJPERES #### Update of Field Action on 05/01/2018, currently the product PACS IMAGE MANAGEMENT SYSTEMS WITHOUT REGISTRATION AT ANVISA: OsiriX, KPACS, DICOM4Chee and eFilm release 1.5 Is duly registered with Anvisa.

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

According to the manifestation of the company, in compliance with RDC 23/2012, the deviation verified was punctual; in the investigation it was found that a failure occurred in a cutting equipment of the packages and a blade detached from the equipment falling into the package. The company is identifying the units still available for pickup. If a customer still identifies any units in their inventory, please contact the company for arrangements regarding product pick-up.

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

The company informs that if the FDP unexpectedly unlocks, it can potentially contact the patient, the operator or the service personnel if they are in the path of the FPD. The severity was classified as "results in serious harm" and the likelihood of recurrence was classified as "not expected".