MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-26 for MESH TSL - PERMACOL? UNKNOWN PERMACOL PRODUCT manufactured by Sofradim Production Sas.
[185896594]
(b)(4). If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185896595]
The patient? S attorney alleged a deficiency against the device. The product was used for therapeutic treatment of a ventral hernia. It was reported that after implant, the patient experienced recurrence, metabolic acidosis, respiratory failure, ileus, sepsis, bowel perforation, anemia, loss of domain, fibrosis, and adhesions. Post-operative patient treatment included bowel resection, iv fluids, iv pressors, antibiotics, tpn, transfusion, hernia repair with new mesh, skin graft, and incidental appendectomy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615742-2020-00639 |
| MDR Report Key | 9883382 |
| Report Source | CONSUMER |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date Mfgr Received | 2020-03-04 |
| Date Added to Maude | 2020-03-26 |
| 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 | LISA HERNANDEZ |
| Manufacturer Street | 60 MIDDLETOWN AVE |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal | 06473 |
| Manufacturer Phone | 2034925563 |
| Manufacturer G1 | SOFRADIM PRODUCTION SAS |
| Manufacturer Street | 116 AVENUE DU FORMANS |
| Manufacturer City | TREVOUX 01600 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 01600 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MESH TSL - PERMACOL? |
| Generic Name | MESH, SURGICAL |
| Product Code | FTM |
| Date Received | 2020-03-26 |
| Model Number | UNKNOWN PERMACOL PRODUCT |
| Catalog Number | UNKNOWN PERMACOL PRODUCT |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SOFRADIM PRODUCTION SAS |
| Manufacturer Address | 116 AVENUE DU FORMANS TREVOUX 01600 FR 01600 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-26 |