FDA Adverse Event
Injury
Summary report: N
UPHOLD VAGINAL SUPPORT SYSTEM
MDR report key: 3172653
·
Received June 17, 2013
Report
- Report Number
- 3005099803-2013-05399
- Event Type
- Injury
- Date Received
- June 17, 2013
- Report Date
- May 28, 2013
- Manufacturer
- BOSTON SCIENTIFIC - MARLBOROUGH
- Product Code
- FTL
- PMA / PMN Number
- K081048
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(6).
Description of Event or Problem · 1
THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. ASSOCIATED MANUFACTURER REPORT # 3005099803-2013-04892 PERTAINS TO THE OTHER DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UPHOLD VAGINAL SUPPORT SYSTEM WAS IMPLANTED (B)(6) 2009. 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 |
|---|---|---|---|---|---|---|---|
| 273498 | UPHOLD VAGINAL SUPPORT SYSTEM | MESH, SURGICAL, POLYMERIC | FTL | BOSTON SCIENTIFIC - MARLBOROUGH | M0068317080 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | ADVANTAGE FIT SYSTEM |