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 |