FDA Adverse Event
Injury
Summary report: N
OBTRYX SYSTEM
MDR report key: 3032821
·
Received April 3, 2013
Report
- Report Number
- 3005099803-2013-02124
- Event Type
- Injury
- Date Received
- April 3, 2013
- Report Date
- March 7, 2013
- Manufacturer
- BOSTON SCIENTIFIC - MARLBOROUGH
- Product Code
- FTL
- PMA / PMN Number
- K040787
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE COMPLAINANT ALSO LISTS DR (B)(6).
Description of Event or Problem · 1
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OBTRYX TRANSOBTURATOR MID-URETHRAL SLING SYSTEM WAS IMPLANTED ON (B)(6) 2008. ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED VAGINAL EROSION, RECURRENT URINARY TRACT/BLADDER INFECTIONS, MESH EROSION, BLADDER PERFORATIONS, INCONTINENCE AND ABDOMINAL/PELVIC PAIN. 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 |
|---|---|---|---|---|---|---|---|
| 136151 | OBTRYX SYSTEM | MESH, SURGICAL, POLYMERIC | FTL | BOSTON SCIENTIFIC - MARLBOROUGH | M0068504000 | 0ML8031701 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |