FDA Adverse Event
Death
Summary report: N
URETEX SYNTHETIC SLING
MDR report key: 2364872
·
Received December 5, 2011
Report
- Report Number
- 9615742-2011-00148
- Event Type
- Death
- Date Received
- December 5, 2011
- Date of Event
- October 2, 2011
- Report Date
- November 7, 2011
- Manufacturer
- SOFRADIM PRODUCTION
- Product Code
- FTL
- PMA / PMN Number
- K012949
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: UROLOGICAL/GYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PT UNDERWENT A PROLAPSE REPAIR PROCEDURE AND WAS IMPLANTED WITH TWO MESHES IN 2008. APPROX 4 MONTHS AGO, THE PT ALLEGEDLY EXPERIENCED EROSION AND PAIN. IN ADDITION, HER BLADDER WAS FLUSHED WITH ANTIBIOTICS WEEKLY DUE TO EROSION INTO HER BLADDER, WHICH CAUSED SEVERE CONSTIPATION. THE PT WAS PRESCRIBED PAIN MEDICATION. THE PT WAS IN SUCH PAIN THAT SHE SHOT HERSELF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | URETEX SYNTHETIC SLING | URETEX SYNTHETIC SLING | FTL | SOFRADIM PRODUCTION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death| O | SYS: PRODUCT IS PRFP01, AND THE LOT # IS 3068750| JOHNSON AND JOHNSON GYNECARE PROLIFT POST REPAIR |