FDA Adverse Event
Injury
Summary report: N
BONE ANCHOR SYSTEM FOR SOFT TISSUE SUPPORT
MDR report key: 3089351
·
Received May 2, 2013
Report
- Report Number
- 3005099803-2013-03334
- Event Type
- Injury
- Date Received
- May 2, 2013
- Report Date
- April 18, 2013
- Manufacturer
- BOSTON SCIENTIFIC - SPENCER
- Product Code
- MBI
- PMA / PMN Number
- K971139
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
THE REPORTED LOT NUMBER,1993437 COULD NOT BE MATCHED TO THE UPN.
Description of Event or Problem · 1
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A VESICA SLING SYSTEM WAS IMPLANTED (B)(6) 1999. ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED PAIN AND SUFFERING, DISABILITY, IMPAIRMENT AND DISFIGUREMENT. 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 |
|---|---|---|---|---|---|---|---|
| 193231 | BONE ANCHOR SYSTEM FOR SOFT TISSUE SUPPORT | FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE | MBI | BOSTON SCIENTIFIC - SPENCER | M0068201300 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |