FDA Adverse Event
Malfunction
Summary report: N
UNKNOWN SOFRADIM PRODUCT
MDR report key: 1479750
·
Received July 8, 2009
Report
- Report Number
- 9615742-2009-00071
- Event Type
- Malfunction
- Date Received
- July 8, 2009
- Report Date
- June 22, 2009
- Manufacturer
- TREVOUX - USS
- Product Code
- FTL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B) (4). (B) (4).
Description of Event or Problem · 1
PROCEDURE TYPE: LAPAROTOMY. ACCORDING TO THE REPORTER: POST HERNIA REPAIR, THE SURGEON HAD CONDUCTED A LAPAROTOMY (FOR PURPOSES UNRELATED TO THE INITIAL HERNIA REPAIR) AND THE MESH WAS 100% COVERED WITH ADHESIONS. PROPER GUIDELINES WERE FOLLOWED DURING IMPLANTATION OF THE MESH AND THERE WERE NO OTHER ISSUES WITH THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN SOFRADIM PRODUCT | PCO MESH | FTL | TREVOUX - USS | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |