FDA Adverse Event
Injury
Summary report: N
SOFRADIM PRODUCT
MDR report key: 2537716
·
Received April 5, 2012
Report
- Report Number
- 9615742-2012-00126
- Event Type
- Injury
- Date Received
- April 5, 2012
- Report Date
- March 6, 2012
- Manufacturer
- SOFRADIM PRODUCTION
- Product Code
- FTL
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: VENTRAL HERNIA REPAIR. ACCORDING TO THE REPORTER: THE SURGEON PLACED MESH 6 MONTHS AGO INTO A LARGER PT AS A BRIDGE DURING VENTRAL HERNIA REPAIR. THE 6 MONTHS POST-OPERATIVELY, THE PT RETURNED WITH A RECURRENCE DUE TO MESH SPLITTING IN HALF. THERE WAS NO HARM DONE TO PT, JUST A SECOND SURGERY. NO OTHER INFORMATION PROVIDED AT THE TIME OF THIS COMPLAINT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOFRADIM PRODUCT | SOFRADIM | FTL | SOFRADIM PRODUCTION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |