FDA Adverse Event
Injury
Summary report: N
UPHOLD VAGINAL SUPPORT SYSTEM
MDR report key: 3140605
·
Received May 31, 2013
Report
- Report Number
- 3005099803-2013-04491
- Event Type
- Injury
- Date Received
- May 31, 2013
- Date of Event
- May 3, 2013
- Report Date
- May 7, 2013
- Manufacturer
- BOSTON SCIENTIFIC - MARLBOROUGH
- Product Code
- FTL
- PMA / PMN Number
- K081048
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). (B)(6).
Description of Event or Problem · 1
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING PLACEMENT OF AN UPHOLD VAGINAL SUPPORT SYSTEM, THE SUTURE BROKE AND REMAINED INSIDE THE MESH THAT WAS FIXED ON THE CERVIX. PULLING THE SUTURE INSIDE THE PATIENT TO REMOVE IT, CAUSED OVER TENSIONING OF THE MESH. THE PHYSICIAN DECIDED TO CUT AS MUCH OF THE SUTURE AS POSSIBLE. REPORTEDLY, NO EXCESSIVE RESISTANCE WAS EXPERIENCED WHEN PULLING OFF THE LEG. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE ¿OK.¿
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 240924 | UPHOLD VAGINAL SUPPORT SYSTEM | MESH, SURGICAL, POLYMERIC | FTL | BOSTON SCIENTIFIC - MARLBOROUGH | M0068317080 | ML00001335 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 | Other |