FDA Adverse Event
Injury
Summary report: N
PINNACLE PELVIC FLOOR REPAIR KITS
MDR report key: 2982292
·
Received February 28, 2013
Report
- Report Number
- 3005099803-2013-01143
- Event Type
- Injury
- Date Received
- February 28, 2013
- Report Date
- February 7, 2013
- 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
Additional Manufacturer Narrative · 1
THE PHYSICIAN REPORTED THE PATIENT'S AGE TO BE (B)(6). THE EVENT DATE IS UNKNOWN.
Description of Event or Problem · 1
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PINNACLE POSTERIOR PELVIC FLOOR REPAIR KIT WAS IMPLANTED ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, POST-PROCEDURE, THE PATIENT PRESENTED WITH UNSPECIFIED COMPLICATIONS. ACCORDING TO THE PHYSICIAN, NO COMPLICATIONS WERE REPORTED POST PROCEDURE. THE PATIENT HAS NOT CONTACTED THE PHYSICIAN'S OFFICE OR RETURNED TO ANY FOLLOW UP APPOINTMENTS. ALL OTHER INFORMATION IS UNKNOWN AND UNAVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 85965 | PINNACLE PELVIC FLOOR REPAIR KITS | MESH, SURGICAL, POLYMERIC | FTL | BOSTON SCIENTIFIC - MARLBOROUGH | M0068317100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |