Data from El Salvador is current through April 2018. All of the data comes from the National Drugs Administration from El Salvador (DNM), 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 El Salvador.
Notas adicionales en la data
Causa
The cause of the sanitary wing is due to a valve failure that prevents the balloon from inflating and deflating properly. if a patient requires circulatory support with an iabp (balloon intra-aortic pump) and the device does not work, or if the treatment is stopped during use without a replacement iabp available, device failure may result in immediate adverse consequences and serious for health, including death. the sanitary registry im011319012017 covers the model cs300 visits the distributor's facilities and requested documentation of imports and stocks, where it was stated that no related imports had been made since 2012 and that the company's knowledge said affected equipment are outside of uses since they were replaced by more recent technology in 2016.
Acción
Professionals and health centers are advised to stop immediately using the products described in the health alert and to demand from the supplier of the same the action plan to solve said defect or the withdrawal of the product. Notice to the population recomending not to use the product and inform the National Drugs Administration about the commercialization, distribution or dispensation of this product within any health establishment.
- Make searches of the product in health centers and establishments that are dedicated to the sale of medical devices
Data from El Salvador is current through April 2018. All of the data comes from the National Drugs Administration from El Salvador (DNM), 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 El Salvador.
Notas adicionales en la data
Causa
- the products have been classified as forged.
- the owner of the product mentions that hypak pre-filled syringes are no longer manufactured.
- it is reported that the dnm will continue surveillance actions, such as the insurance of products, to avoid the sale of them because they represent a risk to the population.
- include within the list of falfra.
Acción
1. Notice to the population not to consume the product and inform the National Drugs Administration about the commercialization, distribution or dispensation of this product within any pharmaceutical establishment.
2. Perform searches of the product in the BPAs or routine searches.
3. Communication of the international alert.
Data from El Salvador is current through April 2018. All of the data comes from the National Drugs Administration from El Salvador (DNM), 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 El Salvador.
Notas adicionales en la data
Causa
- the aforementioned product was investigated, confirming that it does not correspond to the one legitimately manufactured by gsk, presenting difference in the placement of the texts, difference in the barcode, difference in the device, difference in the insert, difference in the watermark in the safety labeling and in the inhaler bottle, the expiration date which does not correspond to the life time of the product. the product can be recognized by consigning the lot number a22m and expiration date june 2019.
- the conditions of manufacture and packaging, the qualitative formula, the quality of the raw materials used and the finished product are unknown.
- include within the list of falfra.
Acción
- Notice to the population not to consume the product and inform the National Drugs Administration about the commercialization, distribution or dispensing of this product within any pharmaceutical establishment.
- Perform searches of the product in the BAPs or routine searches.
- To find the product in existence within the country, a national alert will be issued.
Data from El Salvador is current through April 2018. All of the data comes from the National Drugs Administration from El Salvador (DNM), 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 El Salvador.
Notas adicionales en la data
Causa
Possible false negative or false positive results for hiv infection obtained with the use of the test. because it is possible that the treatment of a patient who is hiv positive is delayed and a subsequent transmission of the infection is reproduced, so there is no certainty of its safety, quality and efficacy.
Acción
1. Withdrawal of medication from the national market.
2. Notice to the population of the non-consumption of the drug product.
3. Verification of the Destruction of the non-compliant medication.
4. Communication of the international alert.
Data from El Salvador is current through April 2018. All of the data comes from the National Drugs Administration from El Salvador (DNM), 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 El Salvador.
Notas adicionales en la data
Causa
The cause of the sanitary alert is due to the possible delivery of insulin, which can cause hypoglycaemia and, in extreme cases, death. the sanitary register im101306072017 covers the minimed model. the distributor's facilities were visited and documentation of imports and inventories was requested, the distributor provided a list of lots that are within the alert, as well as instructions from the manufacturer on how to address said alert. so we proceeded to verify and seal the units identified in the alert that were in the warehouse, also, the company said that they had already notified customers to change the product.
Acción
- Professionals and health centers are advised to stop immediately using the products described in the health alert and to demand from the supplier of the same the action plan to solve said defect or the withdrawal of the product. Notice to the population recomending not to use the product and inform the National Drugs Administration about the commercialization, distribution or dispensation of this product within any health establishment.
- Make searches of the product in health centers and establishments that are dedicated to the sale of medical devices
Data from El Salvador is current through April 2018. All of the data comes from the National Drugs Administration from El Salvador (DNM), 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 El Salvador.
Notas adicionales en la data
Causa
The cause of the alert is the premature exhaustion of the battery causing that patients do not have the normal waiting time of three months for the replacement of the device, some batteries have been exhausted within 24 hours after the patient receives an alert eri (elective substitution indicator). the distributor's facilities were visited and the import documents for the year 2013-2016 were reviewed, finding 4 teams whose model numbers are in accordance with the health alert. for which follow-up was done, identifying the doctors who performed the implantation procedure so that they could contact the patients, this communication was made by the health professionals and a control was planned for the patients.
Acción
Professionals and health centers are advised to stop immediately using the products described in the health alert and to demand from the supplier of the same the action plan to solve said defect or the withdrawal of the product. Notice to the population recomending not to use the product and inform the National Drugs Administration about the commercialization, distribution or dispensation of this product within any health establishment.
- Make searches of the product in health centers and establishments that are dedicated to the sale of medical devices
Data from El Salvador is current through April 2018. All of the data comes from the National Drugs Administration from El Salvador (DNM), 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 El Salvador.
Notas adicionales en la data
Causa
The cause of the alert is that reports indicate that the ventilator can spontaneously re-establish itself during normal operation without an alarm indicating it. after restart, the fan enters the standby mode and does not resume ventilation without intervention. inspection was carried out at the distribution company where they stated that only one equipment was used that was used for demonstrations to customers and that to date there had been no sales in el salvador.
Acción
Notice to the population recomending not to consume the product and inform the National Drugs Administration about the commercialization, distribution or dispensation of this product within any pharmaceutical establishment.
- Perform search of the product in the BPAs or routine searches.
- To find the product in existence within the country, a national alert will be issued.
Data from El Salvador is current through April 2018. All of the data comes from the National Drugs Administration from El Salvador (DNM), 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 El Salvador.
Notas adicionales en la data
Causa
The cause of the alert is battery faults of the ps500 model, which does not last as expected, even the indicator shows load when it does not. the alert is made to the battery is not related to the whole team. it was verified that 6 fans had been marketed to the first of may hospital of the isss which proceeded to change the model of the defective battery after the alert. inspections of the fans of these models have been carried out and the battery that is in health alert has not been found.
Acción
Professionals and health centers are advised to stop immediately using the products described in the health alert and to demand from the supplier of the same the action plan to solve said defect or the withdrawal of the product. Notice to the population recomending not to use the product and inform the National Drugs Administration about the commercialization, distribution or dispensation of this product within any health establishment.
- Make searches of the product in health centers and establishments that are dedicated to the sale of medical devices
Data from El Salvador is current through April 2018. All of the data comes from the National Drugs Administration from El Salvador (DNM), 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 El Salvador.
Notas adicionales en la data
Causa
The cause of the alert is related to the detachment of the polytetrafluoroethylene (ptfe) coating, which serves to reduce friction between devices and facilitate navigation through the vasculature. the delamination of the layer could possibly lead to an embolic occlusion in the cerebral tilt with the risk of a spill and / or death.
Acción
Professionals and health centers are advised to stop immediately using the products described in the health alert and to demand from the supplier of the same the action plan to solve said defect or the withdrawal of the product. Notice to the population recomending not to use the product and inform the National Drugs Administration about the commercialization, distribution or dispensation of this product within any health establishment.
- Make searches of the product in health centers and establishments that are dedicated to the sale of medical devices
Data from El Salvador is current through April 2018. All of the data comes from the National Drugs Administration from El Salvador (DNM), 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 El Salvador.
Notas adicionales en la data
Causa
The cause of the health alert is that the devices present electrical and battery connection problems that may prevent the device from turning on, charging and providing electrical shock therapy in a correct manner, a delay in the delivery of the therapy, resulting in serious injuries to the patient such as permanent damage to organs, brain injuries or death. in the inspection of the distribution company, it was corroborated that they did not have any related equipment.
Acción
Professionals and health centers are advised to stop immediately using the products described in the health alert and to demand from the supplier of the same the action plan to solve said defect or the withdrawal of the product. Notice to the population recomending not to use the product and inform the National Drugs Administration about the commercialization, distribution or dispensation of this product within any health establishment.
- Make searches of the product in health centers and establishments that are dedicated to the sale of medical devices
Data from El Salvador is current through April 2018. All of the data comes from the National Drugs Administration from El Salvador (DNM), 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 El Salvador.
Notas adicionales en la data
Causa
The cause of the alert is due to difficulties in removing the protective cover of the balloon from the catheter, which can lead to problems with inflation and deflation of the balloon. affected lots: 60921g1, 60912g1, 60819g1, 61012g1, 60907g1 the inspection was carried out confirming that 12 units were imported from the affected lots of which only one was commercialized and notified to the health center, the remaining 11 were returned to the manufacturer abbott vascular fedex.
Acción
Professionals and health centers are advised to stop immediately using the products described in the health alert and to demand from the supplier of the same the action plan to solve said defect or the withdrawal of the product. Notice to the population recomending not to use the product and inform the National Drugs Administration about the commercialization, distribution or dispensation of this product within any health establishment.
- Make searches of the product in health centers and establishments that are dedicated to the sale of medical devices
Data from El Salvador is current through April 2018. All of the data comes from the National Drugs Administration from El Salvador (DNM), 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 El Salvador.
Notas adicionales en la data
Causa
- no sanitary registry or imports of the product were found, according to the research carried out by the dnm.
- include within the list of falfra.
Acción
- Notice to the population not to consume the product and inform the National Drugs Administration about the commercialization, distribution or dispensing of this product within any pharmaceutical establishment.
- Perform searches of the product in the BPAs or routine searches.
- To find the product in existence within the country, a national alert will be issued.
Data from El Salvador is current through April 2018. All of the data comes from the National Drugs Administration from El Salvador (DNM), 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 El Salvador.
Notas adicionales en la data
Causa
- original product with trade name neurobion dc 25000 injectable solution, registered in el salvador f044921092011, in box presentation for 1 double chamber ampoule 2ml and corresponding medical sample. on june 23, 2015, a national alert was issued, due to the fact that the counterfeit product was found in the inspections carried out at the cargo terminal of the el salvador international airport.
Acción
- Notice to the population not to consume the product and inform the National Drugs Administration about the commercialization, distribution or dispensing of this product within any pharmaceutical establishment.
- Perform searches of the product in the BPAs or routine searches.
- To find the product in existence within the country, a national alert will be issued.