Panamanian data is current through January 2019. All of the data comes from the Health Ministry (Panama), 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 Panama.
Notas adicionales en la data
Causa
In japan there have been cases of acute generalized exanterriatic pustulosis in patients treated with preparations of piperacicline and hydrated piperacicline / tazobactam (none in the last three years). acute generalized exanthematous pustulosis: cases of acute generalized pustular psoriasis exantematicase have been reported in patients treated with tazobactam / piperacillin hydrate in both japanese coma abroad. on the other hand, cases of acute generalized exanthematous pustulosis have been reported in patients treated with sodium piperacillin in japan.
Panamanian data is current through January 2019. All of the data comes from the Health Ministry (Panama), 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 Panama.
Notas adicionales en la data
Causa
The drug regulatory authority of canada, health canada, conducted a safety review to assess the possible link between the combination of antimicrobial drugs piperacillin and tazobactam or piperacillin alone and the drug reaction with eosinophilia and systemic symptom or dress syndrome by its acronym in english (drug reaction with eosinophilia and systemic symptom) after published cases of dress associated with the combination of these drugs. dress syndrome describes a group of rare but serious and life-threatening adverse reactions to medications, such as fever, severe skin rash with swollen or bare skin on large areas of the body, etc. these reactions usually occur two weeks to two months after starting a medication. .
Panamanian data is current through January 2019. All of the data comes from the Health Ministry (Panama), 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 Panama.
Notas adicionales en la data
Causa
The australian regulatory medicines agency, the therapeutic goods administration (tga), has announced that intrauterine device (iud) information containing 52 mg of levonorgestrel (mirena®) will be reviewed to include information regarding an increased risk of uterine perforation for breastfeeding women during the first 36 weeks after delivery. while it is known that uterine perforation is a rare adverse event associated with the use of intrauterine contraceptive devices, a recent european study has found that the risk of uterine perforation increases in nursing women and during the first 36 weeks after delivery.
Panamanian data is current through January 2019. All of the data comes from the Health Ministry (Panama), 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 Panama.
Notas adicionales en la data
Causa
Following the notification of the mirena® product 20mcg / 24 hours (lntrauterine system) in which the findings found in lot tu01btw of the product cited in the reference had been communicated and consequently to the corrective and preventive actions carried out, it informs that the lot tu01btw which was blocked in the international warehouses of bayer j. cain, has been 100% inspected, no unit being found with the inserter assembled incorrectly. as seen in the following image, part of the primary packaging material of the product is transparent, so the position of the inserter is easily visualized without contamination of the product, due to the above we confirm that all units of the tu01btw lot were inspected to ensure that the inserter was in the correct position.
Panamanian data is current through January 2019. All of the data comes from the Health Ministry (Panama), 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 Panama.
Notas adicionales en la data
Causa
The spanish agency for medicines and health products (aemps) has reported that it has learned, through the competent authorities of serbia, of the distribution in the serbian market of counterfeit condom units of the "durex" trademark. products affected: the aemps statement mentions that falsifications of four different models of "durex" condoms have been detected in 3-unit presentations. on the product label, the model name is in english ("classic", "extra safe", "tickle me" and "feel thin") and the rest of the information in the hungarian, bulgarian, romanian and serbian languages.
Panamanian data is current through January 2019. All of the data comes from the Health Ministry (Panama), 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 Panama.
Notas adicionales en la data
Causa
At the time of the 2017 review, health canada received a total of 1806 complaints associated with the pod and 28 with the pdm. the annual number of complaints by the omnipod increased in the last 3 years, from 154 reported in 2015, 550 in 2016 and 706 from january to november 2017. the following patient results were described in the incidents reported since the last review: 98 hospitalizations, 58 cases of high levels of acid (ketones) in the blood / urine with low blood ph (diabetic ketoacidosis), 824 cases of high blood sugar levels (hyperglycemia), 19 cases of low blood sugar levels (hypoglycemia), 41 cases of skin irritation and 1 death. at this time, there is not enough information to conclude that these results were related to the omnipod's malfunction. in 215 complaints, no consequences were reported for the patient. according to the manufacturer's analysis, the rates of complaints about the device malfunction (failure key modes) have increased, but are still considered low. these dysfunctions include pod error or danger alarm during operation, occlusion alarm (to warn the patient of a possible insulin administration problem), skin irritation and adhesive problems, needle mechanism failure and patients who do not they are sure if the capsule is administering insulin. as a result of the analysis of the causes of the malfunctions and the measures adopted, the manufacturer explained that pod errors and alarms are safety measures to ensure that any risk of incorrect administration of insulin is corrected quickly. this helps ensure that the user's blood sugar level is not too high or too low. the manufacturer also discussed some design changes that are underway to reduce possible malfunctions with the device. in addition, the review of the available information concluded that the increase in the number of complaints observed seemed to be related to a greater number of omnipod sales. conclusion and actions: the health canada safety review concluded that there is no new security risk for omnipod. the safety information for this medical device is appropriate in this memento. health canada will continue to monitor the safety information that involves omnipod to identify and evaluate potential damages. health canada will take appropriate and timely measures as long as new health risks are identified.
Panamanian data is current through January 2019. All of the data comes from the Health Ministry (Panama), 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 Panama.
Notas adicionales en la data
Causa
The fda warns health professionals not to use treanda lnjection (45 mg i 0.5 ml or 180 mg i 2 ml solution) with closed system transfer devices (cctd), adapters and syringes containing polycarbonate or acrylonitrile- butadiene-styrene (abs). most commercialized cstds contain polycarbonate or abs and are not compatible with treanda injection (45 mg i 0.5 ml or 180 mg i 2 ml solution). n, n-dimethylacetamide (oma), an ingredient in treanda injection (45 mg i 0.5 ml or 180 mg i 2 ml solution), is incompatible with polycarbonate or abs. devices containing polycarbonate or abs dissolve when they come into contact with oma. this can lead to device failure, possible product contamination and possible serious adverse health consequences, including skin reactions in health professionals who prepare and administer this product; and the risk of small obstruction of blood vessels in patients.
Panamanian data is current through January 2019. All of the data comes from the Health Ministry (Panama), 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 Panama.
Notas adicionales en la data
Causa
In panama, the original product, "condones vive original", a contraceptive device, manufactured by thai nippon rubber industry public company limited, thailand, with commercial presentation of white cardboard box in strips x 3 units is registered in panama. the company authorized for marketing has filed complaints that are circulating in stores, supermarkets and other establishments, a condo of doubtful origin, bears the name condones vive original, does not comply with the quality specifications declared in the sanitary registry, the material of packaging is different, the primary or secondary label are different, declares comma manufacturer: karex industries sdn.Bhd. costa rica, and is sold in a transparent plastic bag in long strips of six (6) units, or in a yellow box in strip for six (6); lot l23170806 and expiration date 03/2023.
Panamanian data is current through January 2019. All of the data comes from the Health Ministry (Panama), 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 Panama.
Notas adicionales en la data
Causa
Coopervision, after the investigation of the avaira manufacturing lines, has detected that certain batches of avaira sphere contact lenses do not meet the quality requirements due to the presence of a residue (silicone oil). the presence of this residue can cause blurred vision, discomfort, severe eye pain or eye injuries that require medical treatment. not all patients experience the same symptoms.
Panamanian data is current through January 2019. All of the data comes from the Health Ministry (Panama), 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 Panama.