FDA Adverse Event
Injury
Summary report: N
PINNACLE PELVIC FLOOR REPAIR KITS
MDR report key: 2760618
·
Received September 26, 2012
Report
- Report Number
- 3005099803-2012-04301
- Event Type
- Injury
- Date Received
- September 26, 2012
- Report Date
- September 6, 2012
- Manufacturer
- BOSTON SCIENTIFIC - MARLBOROUGH
- Product Code
- FTL
- PMA / PMN Number
- K071957
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
NOTE: THIS MFR REPORT PERTAINS TO THE FIRST OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO ASSOCIATED MFR REPORT# 3005099803-2012-04302 FOR A DESCRIPTION OF THE OTHER DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PINNACLE POSTERIOR PELVIC FLOOR REPAIR KIT WAS IMPLANTED ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, POST-PROCEDURE, THE PATIENT EXPERIENCED PAIN AND DISABILITY. ALL OTHER INFORMATION IS UNKNOWN AND UNAVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PINNACLE PELVIC FLOOR REPAIR KITS | MESH, SURGICAL, POLYMERIC | FTL | BOSTON SCIENTIFIC - MARLBOROUGH | M0068317100 | 1ML0030102 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | UPHOLD VAGINAL SUPPORT SYSTEM |