FDA Adverse Event
Malfunction
Summary report: N
UNK SOFRADIM PRODUCT
MDR report key: 1010123
·
Received March 10, 2008
Report
- Report Number
- 9615742-2008-00007
- Event Type
- Malfunction
- Date Received
- March 10, 2008
- Report Date
- February 13, 2008
- Manufacturer
- TREVOUX - USS
- Product Code
- FTL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INITIAL REPORT SENT TO FDA ON 03/07/2008.
Description of Event or Problem · 1
PROCEDURE: UROLOGICAL. ACCORDING TO THE REPORTER: IT WAS REPORTED THAT ONE DAY FOLLOWING A URETEX SLING PROCEDURE IN 2007, THE PT DEVELOPED ITCHING AND DIZZINESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNK SOFRADIM PRODUCT | SURGICAL MESH | FTL | TREVOUX - USS | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |