FDA Adverse Event
Malfunction
Summary report: N
UPHOLD VAGINAL SUPPORT SYSTEM
MDR report key: 2240042
·
Received September 8, 2011
Report
- Report Number
- 3005099803-2011-02950
- Event Type
- Malfunction
- Date Received
- September 8, 2011
- Date of Event
- August 17, 2011
- Report Date
- August 17, 2011
- Manufacturer
- BOSTON SCIENTIFIC - MARLBOROUGH
- Product Code
- FTL
- PMA / PMN Number
- K081048
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING PREPARATION FOR A VAGINAL PROLAPSE REPAIR PROCEDURE USING AN UPHOLD VAGINAL SUPPORT SYSTEM, AS THE TECHNICIAN TEST-FIRED THE CAPIO DEVICE, THE NEEDLE DETACHED FROM A LEG ASSEMBLY. THE NEEDLE REPORTEDLY DETACHED OUTSIDE OF THE PATIENT. THE PHYSICIAN COMPLETED THE PROCEDURE WITH ANOTHER UPHOLD VAGINAL SUPPORT SYSTEM WITH NO COMPLICATIONS TO THE PATIENT, WHO IS REPORTEDLY "GREAT" AND IS OVER 18 YEARS OF AGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UPHOLD VAGINAL SUPPORT SYSTEM | MESH, SURGICAL, POLYMERIC | FTL | BOSTON SCIENTIFIC - MARLBOROUGH | M0068317080 | ML00000149 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |