FDA Adverse Event
Malfunction
Summary report: N
UPHOLD VAGINAL SUPPORT SYSTEM
MDR report key: 2122383
·
Received June 13, 2011
Report
- Report Number
- 3005099803-2011-02005
- Event Type
- Malfunction
- Date Received
- June 13, 2011
- Date of Event
- May 16, 2011
- Report Date
- May 20, 2011
- Manufacturer
- BOSTON SCIENTIFIC - MARLBOROUGH
- Product Code
- FTL
- PMA / PMN Number
- K081048
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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 THE PHYSICIAN WAS PULLING THE FIRST LEG ASSEMBLY THROUGH THE PATIENT'S LEFT SACROSPINOUS LIGAMENT, THE NEEDLE, WITH A LITTLE BIT OF SUTURE AT THE END, DETACHED. THEN, AS THE PHYSICIAN GRABBED THE DILATOR, THE DILATOR DETACHED AS WELL. REPORTEDLY, THE DETACHMENT OCCURED VERY EASILY, AND NO PIECES FELL LOOSE INSIDE THE PATIENT. THE PHYSICIAN REMOVED THE DEVICE AND COMPLETED THE PROCEDURE WITH ANOTHER UPHOLD VAGINAL SUPPORT SYSTEM WITH NO COMPLICATIONS TO THE PATIENT, WHO IS REPORTEDLY FINE AND IS (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UPHOLD VAGINAL SUPPORT SYSTEM | MESH, SURGICAL, POLYMERIC | FTL | BOSTON SCIENTIFIC - MARLBOROUGH | M0068317080 | 1ML0072002 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |