N
Patient 1
CONCOMITANT PRODUCTS: PCO9 PARIETEX COMP 3D PY 9 CIR NO THRX1, (LOT # PLJ00313), UNKNOWN PROTACK, (LOT # UNKNOWN). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
MAUDE MDR 9891803
- MDR report key
- 9891803
- Report number
- 9615742-2020-00750
- Event key
- 0
- Event type
- 3
- Date received
- 2020-03-27
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 3
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- LISA HERNANDEZ
- Address
- 60 MIDDLETOWN AVE NORTH HAVEN CT 06473 US
- Phone
- 203-203-2034
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | MESH SOFRADIM - PARIETEX? COMPOSITE MESH | MESH, SURGICAL, POLYMERIC | SOFRADIM PRODUCTION SAS | FTL | PCO2015 | PCO2015 | PKE00462 | * | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-27 | 0 | 1. R |
Event Narratives#
D
Patient 1
THE PATIENT?S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR LAPAROSCOPIC THERAPEUTIC TREATMENT OF AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED INFECTION AND ABSCESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.