MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2015-11-04 for PERMACOL 15X20 1.5MM 5152-150 manufactured by Sofradim Production.
[30405610]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[30405611]
According to the reporter, following a procedure to resect a tumor and repair an abdominal evisceration, a mesh implant was placed and prophylactic antibiotic therapy was started. 24 hours following the procedure, the patient presented with painful edema, erythema and fever. It was diagnosed as bacteremia and necrotizing fasciitis. Another antibiotic was added to the therapy and the patient was taken to surgery. Nothing abnormal was found during surgery. Cultures were taken from the edges of the defect and sent to pathology. Klebsiella pneumoniae (a nosocomial germ) was found and the pathology results are pending. The patient remains in the intensive care unit (icu). Additional information has been requested but not yet received.
Patient Sequence No: 1, Text Type: D, B5
[32986825]
(b)(4). The sample was not returned for investigation. Requests for additional information have been unsuccessful. A review of the device history record has been performed. This review confirmed that this lot of products was released according to specifications. A search of the global complaints database revealed that this was the only report on file for this lot of product. The report has been added to the product complaints database which is monitored for similar occurrences.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9615742-2015-00102 |
| MDR Report Key | 5201644 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2015-11-04 |
| Date of Report | 2015-11-12 |
| Date of Event | 2015-10-07 |
| Date Mfgr Received | 2015-11-12 |
| Device Manufacturer Date | 2014-07-23 |
| Date Added to Maude | 2015-11-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SHARON MURPHY |
| Manufacturer Street | 60 MIDDLETOWN AVE |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal | 06473 |
| Manufacturer Phone | 2034925267 |
| Manufacturer G1 | SOFRADIM PRODUCTION |
| Manufacturer Street | 116 AVENUE DU FORMANS |
| Manufacturer City | TREVOUX |
| Manufacturer Country | FR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERMACOL 15X20 1.5MM |
| Generic Name | MESH, SURGICAL, COLLAGEN, LARGE ABDOMINAL WALL DEFECTS |
| Product Code | OXK |
| Date Received | 2015-11-04 |
| Model Number | 5152-150 |
| Catalog Number | 5152-150 |
| Lot Number | AOG0669 |
| Device Expiration Date | 2019-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SOFRADIM PRODUCTION |
| Manufacturer Address | 116 AVENUE DU FORMANS TREVOUX FR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2015-11-04 |