FDA Adverse Event
Injury
Summary report: N
UPHOLD VAGINAL SUPPORT SYSTEM
MDR report key: 3123131
·
Received May 21, 2013
Report
- Report Number
- 3005099803-2013-04109
- Event Type
- Injury
- Date Received
- May 21, 2013
- Report Date
- May 2, 2013
- Manufacturer
- BOSTON SCIENTIFIC - MARLBOROUGH
- Product Code
- FTL
- PMA / PMN Number
- K081048
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THIS REPORT PERTAINS TO ONE OF THREE DEVICES USED DURING THE SAME PROCEDURE. ASSOCIATED MANUFACTURER REPORT # 3005099803-2013-04253 AND ASSOCIATED MANUFACTURER REPORT # 3005099803-2013-04258 PERTAIN TO THE OTHER DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UPHOLD VAGINAL SUPPORT SYSTEM WAS IMPLANTED (B)(6), 2011. ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED AN UNKNOWN INJURY. 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 |
|---|---|---|---|---|---|---|---|
| 224997 | UPHOLD VAGINAL SUPPORT SYSTEM | MESH, SURGICAL, POLYMERIC | FTL | BOSTON SCIENTIFIC - MARLBOROUGH | M0068317080 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | ADVANTAGE TRANSVAGINAL MID-URETHRAL SLING SYSTEM| ADVANTAGE FIT SYSTEM |