FDA Adverse Event
Injury
Summary report: N
UPHOLD VAGINAL SUPPORT SYSTEM
MDR report key: 2103145
·
Received May 25, 2011
Report
- Report Number
- 3005099803-2011-01856
- Event Type
- Injury
- Date Received
- May 25, 2011
- Date of Event
- April 28, 2011
- Report Date
- May 3, 2011
- Manufacturer
- BOSTON SCIENTIFIC - MARLBOROUGH
- Product Code
- FTL
- PMA / PMN Number
- K081048
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ND, 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 AN ANTERIOR REPAIR PROCEDURE USING AN UPHOLD VAGINAL SUPPORT SYSTEM, AS A LEG ASSEMBLY WAS BEING THROWN THROUGH THE LIGAMENT, THE NEEDLE DETACHED FROM THE SUTURE. IT IS UNKNOWN IF THE NEEDLE FELL LOOSE INSIDE THE PATIENT. THE PHYSICIAN RETRIEVED THE DETACHED NEEDLE AND COMPLETED THE PROCEDURE WITH ANOTHER UPHOLD VAGINAL SUPPORT SYSTEM WITH NO COMPLICATIONS TO THE PATIENT, WHO IS REPORTEDLY FINE 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 | 1ML1022205 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |