FDA Adverse Event
Injury
Summary report: N
PARIETEX
MDR report key: 8400376
·
Received March 7, 2019
Report
- Report Number
- 9615742-2019-00416
- Event Type
- Injury
- Date Received
- March 7, 2019
- Report Date
- March 27, 2026
- Manufacturer
- SOFRADIM PRODUCTION SAS
- Product Code
- FTL
- UDI-DI
- 20884521176420
- PMA / PMN Number
- K101519
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A RIGHT INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED SEVERE PAIN, RECURRENCE, LACK OF INCORPORATION, MESH FOLDED OVER, AND MESH BUNCHED. THE DEVICE HAD BEEN USED WITH A BARD VENTRALEX ST HERNIA PATCH (5950007). POST-OPERATIVE PATIENT TREATMENT INCLUDED SURGICAL REVISION AND EXCISION OF MESH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 193570 | PARIETEX | MESH, SURGICAL, POLYMERIC | FTL | SOFRADIM PRODUCTION SAS | PNP6X3 | SOL0110X | 20884521176420 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Male | Required Intervention |