German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 Germany.
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 recall data from the U.S. and France.
Notas adicionales en la data
Acción
ANSM has been informed of the implementation of a recall made by Medtronic. The users concerned received the attached mail (25/06/2013) (142 KB). This recall follows the broadcast of a first security message to users of these devices, February 18, 201..
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: codman neuro trufill n-bca liquid embolic system
the united states food and drug administration (fda) has issued a medical device safety alert concerning trufill n-bca liquid embolic system [product code: 631400 & 631500], manufactured by codman neuro.
according to the fda, trufill n-bca is indicated for embolization of cerebral arteriovenous malformations (avms) when presurgical devascularization is desired. in october 2013, the manufacturer identified an incorrect statement in the product's instructions for use (ifu) that described suggested mixing ratios for use in certain treatment conditions.
the manufacturer is informing physicians of this incorrect statement and updating the product's ifu. the product's ifu incorrectly noted: "a 2:1 (67% ethiodized oil / 33% nbca) for feeding pedicle injections close to the nidus at high flow rates where venous opacification occurs on contrast injections within 1/2 second."
the correct information should have stated: "a 2:1 (67% ethiodized oil / 33% nbca) for intranidal injections without av fistulae or high flow rates in order to more deeply penetrate the nidus."
the use of incorrectly mixed product can result in the liquid mixture solidifying too slowly in unintended areas, which may lead to embolization or reflux into arteries and pulmonary vessels. this could result in significant impact to the patient, including neurological deficits, pulmonary emboli and possibly death.
the manufacturer advises all affected users to review the correction notice and other product literature to ensure proper mixing procedures are followed.
according to the local supplier, the affected products were not distributed in hong kong.
for details, please refer to fda websites:http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm382556.Htm
http://www.Fda.Gov/safety/recalls/ucm382496.Htm
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 23 january 2014.
Italian data is current through August 2018. All of the data comes from Ministero della Salute (Health Ministry), 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 Italy.
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 recall data from the U.S. and France.
Notas adicionales en la data
Acción
ANSM has been informed of the implementation of a recall by Medtronic. The users concerned received the attached mail (23/06/2014) (69 KB). This safety action is registered with the ANSM under the number 2014 08201. You will be able to consult its progress on the Directory of the signaling of materiovigilance by entering this n ° of registration.
Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, 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 recall data from the U.S. and Poland.
Notas adicionales en la data
Acción
Medtronic safety note for Neurosurgery regarding the withdrawal and use of some batches of external drainage and monitoring systems Duet
Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, 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 recall data from the U.S. and Poland.
Notas adicionales en la data
Acción
Brainlab AG safety note regarding the cranial navigation system - update
Data from Singapore is current through September 2018. All of the data comes from the Health Sciences Authority (HSA), 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 recall data from the U.S. and Singapore.
German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 Germany.
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.
Notas adicionales en la data
The following factors may have a significant effect on the overall navigation accuracy of the device: (1) Large distance between the reference star and the region of interest; (2) Large changes in camera positioning relative to the reference star during the procedure. Such occurrences may intensify small inaccuracies resulting from specific steps of the complex navigation procedure. In the worst case scenario, such inaccuracies may result in inaccurate display of the instruments by the navigation system, compared to the actual anatomy of the patient. Brainlab has released a new version of Brainlab Cranial software (version 2.1.2) to fix the problem. Until the new software is installed, users of the product should follow the instructions already provided by the company "Measures to Improve the Precision of Skull Navigation" and read the warning message issued by the company for this field action.
Causa
Certain occurrences may intensify inaccuracies in the system, which may result in inaccurate display of the instruments by the navigation system compared to the actual anatomy of the patient.
German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 Germany.
Russian data is current through January 2019. All of the data comes from the Federal Service for Surveillance in Healthcare, 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 recall data from the U.S. and Russia.
Finnish data is current through April 2018. All of the data comes from Valvira - National Supervisory Authority for Welfare and Health, 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 recall data from the U.S. and Finland.
Notas adicionales en la data
Source: FSCA
Causa
Device failure / feature before use - packing - operating instructions.
Czech data is current through July 2018. All of the data comes from the Czech Public Registry of Medical Devices, 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 the Czech Republic.
Japanese data is current through August 2018. All of the data comes from the Japanese Pharmaceuticals and Medical Devices Agency, 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 recall data from the U.S. and Japan.
Belgian data is current through November 2018. All of the data comes from the Federal Agency for Medicines and Health Products, 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 Belgium.
German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 Germany.
Italian data is current through August 2018. All of the data comes from Ministero della Salute (Health Ministry), 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 Italy.
Lebanese data is current through July 2018. All of the data comes from the Ministry of Public Health (Republic of Lebanon), 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 recall data from the U.S. and Lebanon.
Lebanese data is current through July 2018. All of the data comes from the Ministry of Public Health (Republic of Lebanon), 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 recall data from the U.S. and Lebanon.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: penumbra 3d revascularization device
the united states food and drug administration (fda) has issued a medical device safety alert concerning penumbra 3d revascularization device, manufactured by penumbra inc. [lot numbers: c00644, c00645, c00646, c00717; distribution dates: 15 may 2017 to 7 june 2017; manufacturing dates: 21 march 2017 to 28 april 2017]
the manufacturer is recalling the penumbra 3d revascularization device because there is a risk of the delivery wire breaking or separating during use. fractured pieces of the delivery wire could be left inside the patient’s brain bloodstream, and this or the attempts made to retrieve the fractured pieces, can make the stroke worse. this can also cause other serious adverse health consequences such as continued blockage of blood vessels, completion of the stroke, and death.
affected users are advised to identify and remove any affected 3d revascularization devices from inventory and quarantine.
for details, please refer to the fda websites:
https://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm567913.Htm
https://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm567990.Htm
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 24 july 2017.
Lebanese data is current through July 2018. All of the data comes from the Ministry of Public Health (Republic of Lebanon), 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 recall data from the U.S. and Lebanon.
Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 recall data from the U.S. and Colombia.
Notas adicionales en la data
Causa
The manufacturer has detected the risk of the supply cord splitting or separating during use, these pieces could be left inside the patient's cerebral bloodstream, these fragments or the attempts made to recover them could have serious consequences, leading to possible events adverse in patients.
Lebanese data is current through July 2018. All of the data comes from the Ministry of Public Health (Republic of Lebanon), 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 recall data from the U.S. and Lebanon.
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.
Notas adicionales en la data
For the affected product that has not been used, Medtronic requests immediate action. 1. Remove and quarantine all unused products in your inventory. 2. Return the affected products to the Auto Suture (PLC). Your representative can help facilitate the return of the product as needed. 3. Complete the Customer Confirmation Form, and return it to the Auto Suture (PLC). If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link Additional information: - Date of identification of the problem by the company: 01/03/2018 - Date of notification notice for Anvisa: 08/03/2018 The company that owns the affected product is responsible for contacting its customers in due time. to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "
Causa
Partial detachment or separation of the mindframe capture tm lp device may lead to vessel damage or the foreign body of the device may clog the bloodstream. potential complications or irreversible damage associated with this problem include, but are not limited to: prolonged procedure, incomplete treatment, internal damage, vasospasm, dissection, intracranial hemorrhagic, hematoma, transient ischemic attack, ischemic stroke / cerebral infarction, neurological deficit, and / or death. until february 23, 2018, auto suture (medtronic plc) has received a total of twenty (20) partial release or separation reports from the mindframe capturetm lp device. there were a total of three (3) reported serious damage reports, which include two (2) death reports potentially associated with this problem, we also report that these reports occurred outside brazil.
Acción
Field Action Code FA804 triggered under the responsibility of the company Auto Suture do Brasil Ltda. It will make recollection.