FDA Adverse Event
Injury
Summary report: N
UPHOLD VAGINAL SUPPORT SYSTEM
MDR report key: 3667824
·
Received March 7, 2014
Report
- Report Number
- 3005099803-2014-01272
- Event Type
- Injury
- Date Received
- March 7, 2014
- Report Date
- February 14, 2014
- Manufacturer
- BOSTON SCIENTIFIC - MARLBOROUGH
- Product Code
- OTP
- PMA / PMN Number
- K081048
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
LITERATURE - EVENT PUBLISHED IN THE FOLLOWING JOURNAL ARTICLE: PROGRÈS EN UROLOGIE 2012: 22; 1077-1083.
Description of Event or Problem · 1
PER THE PUBLISHED JOURNAL ARTICLE, AN UPHOLD VAGINAL SUPPORT SYSTEM WAS IMPLANTED INTO THE PATIENT ON AN UNSPECIFIED DATE FROM OCTOBER 2009 TO JANUARY 2012. ACCORDING TO THE ARTICLE, THE PATIENT REQUIRED MESH REVISION SURGERY FOR MESH EXPOSURE (WITHOUT COMPLETE REMOVAL OF THE MESH). ALL OTHER INFORMATION IS UNKNOWN. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 139380 | UPHOLD VAGINAL SUPPORT SYSTEM | MESH, SURGICAL, SYNTHETIC | OTP | BOSTON SCIENTIFIC - MARLBOROUGH | M0068317080 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |