FDA Adverse Event
Injury
Summary report: N
PINNACLE PELVIC FLOOR REPAIR KITS
MDR report key: 2925446
·
Received January 22, 2013
Report
- Report Number
- 3005099803-2013-00312
- Event Type
- Injury
- Date Received
- January 22, 2013
- Report Date
- December 31, 2012
- Manufacturer
- BOSTON SCIENTIFIC - MARLBOROUGH
- Product Code
- FTL
- PMA / PMN Number
- K071957
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
TWO IMPLANT DATES WERE PROVIDED: (B)(6) 2008 AND (B)(6) 2010. HOWEVER, IT WAS REPORTED THAT THE PATIENT WAS ALSO IMPLANTED WITH THREE OTHER PRODUCTS, AND IT IS NOT SPECIFIED WHICH PRODUCT WAS IMPLANTED ON WHICH DATE.
Description of Event or Problem · 1
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PINNACLE POSTERIOR PELVIC FLOOR REPAIR KIT WAS IMPLANTED INTO THE PATIENT. ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED INJURIES (SPECIFICS UNKNOWN). 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 |
|---|---|---|---|---|---|---|---|
| 30478 | PINNACLE PELVIC FLOOR REPAIR KITS | MESH, SURGICAL, POLYMERIC | FTL | BOSTON SCIENTIFIC - MARLBOROUGH | M0068317100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |