FDA Adverse Event
Death
Summary report: N
SYMBOTEX
MDR report key: 11917137
·
Received June 1, 2021
Report
- Report Number
- 9615742-2021-01428
- Event Type
- Death
- Date Received
- June 1, 2021
- Report Date
- June 1, 2021
- Manufacturer
- SOFRADIM PRODUCTION SAS
- Product Code
- FTL
- UDI-DI
- 10884521190399
- PMA / PMN Number
- K142908
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, 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 FLANK INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED CHRONIC PAIN, ADHESIONS, INFECTIONS, CHRONIC WOUND, AND FISTULA. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND WOUND VAC. INFORMATION RECEIVED INDICATES THE PATIENT IS DECEASED. NO INFORMATION WAS PROVIDED REGARDING THE CIRCUMSTANCES OF EXPIRATION OR ANY ASSOCIATION WITH THIS DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 810304 | SYMBOTEX | MESH, SURGICAL, POLYMERIC | FTL | SOFRADIM PRODUCTION SAS | SYM1510OS | POFF0761X | 10884521190399 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death| R |