FDA Adverse Event
Malfunction
Summary report: N
UPHOLD VAGINAL SUPPORT SYSTEM
MDR report key: 2101273
·
Received May 24, 2011
Report
- Report Number
- 3005099803-2011-01855
- Event Type
- Malfunction
- Date Received
- May 24, 2011
- Date of Event
- May 3, 2011
- Report Date
- May 3, 2011
- Manufacturer
- BOSTON SCIENTIFIC - MARLBOROUGH
- Product Code
- FTL
- PMA / PMN Number
- K081048
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ND, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Description of Event or Problem · 1
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING UNPACKING, AS AN UPHOLD VAGINAL SUPPORT SYSTEM WAS BEING OPENED, THE PACKAGING WAS DISCOVERED TO BE DAMAGED. REPORTEDLY, ONE CORNER OF THE OUTER BOX PACKAGING WAS CRUSHED, THE SEAL ON ONE SIDE OF THE INNER BOX PACKAGING APPEARED TO BE COMPROMISED, AND THE STERILITY OF THE PRODUCT WAS IN QUESTION. THE DEVICE WAS REPORTEDLY NOT USED FOR ANY PROCEDURE AND WAS DISPOSED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UPHOLD VAGINAL SUPPORT SYSTEM | MESH, SURGICAL, POLYMERIC | FTL | BOSTON SCIENTIFIC - MARLBOROUGH | M0068317080 | 1ML0083103 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |