FDA Adverse Event
Injury
Summary report: N
PINNACLE PELVIC FLOOR REPAIR KITS
MDR report key: 2992767
·
Received March 7, 2013
Report
- Report Number
- 3005099803-2013-01096
- Event Type
- Injury
- Date Received
- March 7, 2013
- Report Date
- February 13, 2013
- Manufacturer
- BOSTON SCIENTIFIC - MARLBOROUGH
- Product Code
- FTL
- PMA / PMN Number
- K071957
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
EXACT PATIENT AGE IS UNKNOWN BUT IS OVER 18 YEARS.
Description of Event or Problem · 1
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE PATIENT WAS IMPLANTED WITH A PINNACLE POSTERIOR PELVIC FLOOR REPAIR KIT DURING A PROCEDURE ON (B)(6) 2008. ACCORDING TO THE COMPLAINANT, POST-PROCEDURE, THE PATIENT EXPERIENCED COMPLICATIONS (SPECIFICS UNKNOWN). ACCORDING TO THE PHYSICIAN, THE PATIENT DID NOT FOLLOW UP WITH ANY COMPLAINTS OR COMPLICATIONS. ALL OTHER INFORMATION IS UNKNOWN. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 97326 | PINNACLE PELVIC FLOOR REPAIR KITS | MESH, SURGICAL, POLYMERIC | FTL | BOSTON SCIENTIFIC - MARLBOROUGH | M0068317100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |