FDA Adverse Event
Other
Summary report: N
SOFRADIM PRODUCT URETEX SUPPORT PP TRANSOBTURA2 KIT X2
MDR report key: 2510449
·
Received March 26, 2012
Report
- Report Number
- 9615742-2012-00099
- Event Type
- Other
- Date Received
- March 26, 2012
- Report Date
- December 1, 2015
- Manufacturer
- SOFRADIM PRODUCTION
- Product Code
- FTL
- PMA / PMN Number
- K041176
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
(B)(4). NOTE: THIS REPORT CORRESPONDS WITH BARD'S REPORT #(B)(4) FOR AN "UNKNOWN URETEX".
Description of Event or Problem · 1
PROCEDURE: UROLOGICAL/GYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PATIENT UNDERWENT A REPAIR PROCEDURE AND THE PATIENT ALLEGEDLY EXPERIENCED PAIN AND INJURY. PATIENT HAS UNDERGONE OR WILL UNDERGO CORRECTIVE SURGERY OR SURGERIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOFRADIM PRODUCT URETEX SUPPORT PP TRANSOBTURA2 KIT X2 | SOFRADIM PRODUCT URETEX SUPPORT | FTL | SOFRADIM PRODUCTION | SHC00202 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Female | Required Intervention| O |