FDA Adverse Event
Injury
Summary report: N
SOFRADIM PRODUCT
MDR report key: 2236870
·
Received August 31, 2011
Report
- Report Number
- 9615742-2011-00080
- Event Type
- Injury
- Date Received
- August 31, 2011
- Date of Event
- May 1, 2006
- Report Date
- August 1, 2011
- Manufacturer
- SOFRADIM PRODUCTION
- Product Code
- FTL
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). NOTE: THIS REPORT CORRESPONDS WITH BARD'S REPORT #313892 FOR AN "PUBOVAGINAL SLING".
Description of Event or Problem · 1
PROCEDURE: UROLOGICAL/GYNECOLOGICAL. ACCORDING TO THE RPTR: THE PT HAD MESH IMPLANTED AND ALLEGEDLY EXPERIENCED PAIN AND INJURY. PT HAS UNDERGONE OR WILL UNDERGO CORRECTIVE SURGERY OR SURGERIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOFRADIM PRODUCT | PUBOVAGINAL SLING | FTL | SOFRADIM PRODUCTION | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |