FDA Adverse Event
Injury
Summary report: N
UPHOLD VAGINAL SUPPORT SYSTEM
MDR report key: 2955735
·
Received February 11, 2013
Report
- Report Number
- 3005099803-2013-00670
- Event Type
- Injury
- Date Received
- February 11, 2013
- Date of Event
- January 15, 2013
- Report Date
- January 17, 2013
- Manufacturer
- BOSTON SCIENTIFIC - MARLBOROUGH
- Product Code
- FTL
- PMA / PMN Number
- K081048
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ZA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4) NEEDLE DETACHMENT. (B)(6).
Description of Event or Problem · 1
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UPHOLD VAGINAL SUPPORT SYSTEM WAS USED DURING AN ANTERIOR AND POSTERIOR REPAIR PROCEDURE. AS THE PHYSICIAN WAS PULLING THE FIRST LEG ASSEMBLY THROUGH THE LIGAMENT WITH THE CAPIO DEVICE, THE NEEDLE DETACHED AND FELL INSIDE THE PATIENT. THE PHYSICIAN ATTEMPTED TO LOOK FOR THE DETACHED NEEDLE BY PALPATION BUT WAS UNSUCCESSFUL, SO THE NEEDLE WAS LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THE SAME UPHOLD MESH AND A STAND-ALONE CAPIO DEVICE, WITH NO COMPLICATIONS TO THE PATIENT, WHO WAS STABLE AT THE CONCLUSION OF THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 57923 | UPHOLD VAGINAL SUPPORT SYSTEM | MESH, SURGICAL, POLYMERIC | FTL | BOSTON SCIENTIFIC - MARLBOROUGH | M0068317080 | ML00000801 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Other |