FDA Adverse Event
Injury
Summary report: N
UPHOLD VAGINAL SUPPORT SYSTEM
MDR report key: 2862925
·
Received December 10, 2012
Report
- Report Number
- 3005099803-2012-05922
- Event Type
- Injury
- Date Received
- December 10, 2012
- Report Date
- November 12, 2012
- Manufacturer
- BOSTON SCIENTIFIC - MARLBOROUGH
- Product Code
- FTL
- PMA / PMN Number
- K081048
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
ACCORDING TO THE PHYSICIAN, THERE WERE NO PROCEDURAL COMPLICATIONS. POST PROCEDURE, THE PATIENT REPORTED SIDE EFFECTS DUE TO PAIN MEDICATION AND CONTRACTED A URINARY TRACT INFECTION (UTI). DURING FOLLOW-UP 6 WEEKS POST PROCEDURE, THE PATIENT REPORTED THAT SHE FELT GREAT. THE PHYSICIAN NOTED NO ISSUES WITH THE DEVICE. ALL OTHER INFORMATION IS UNKNOWN AND UNAVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UPHOLD VAGINAL SUPPORT SYSTEM WAS IMPLANTED ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, POST-PROCEDURE, THE PATIENT PRESENTED WITH UNSPECIFIED COMPLICATIONS. ALL OTHER INFORMATION IS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UPHOLD VAGINAL SUPPORT SYSTEM | MESH, SURGICAL, POLYMERIC | FTL | BOSTON SCIENTIFIC - MARLBOROUGH | M0068317080 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |