FDA Adverse Event
Injury
Summary report: N
OBTRYX SYSTEM
MDR report key: 2873691
·
Received December 14, 2012
Report
- Report Number
- 3005099803-2012-06109
- Event Type
- Injury
- Date Received
- December 14, 2012
- Report Date
- November 29, 2012
- 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
Description of Event or Problem · 1
NOTE: THIS MFR REPORT PERTAINS TO THE FIRST OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO ASSOCIATED MFR REPORT# 3005099803-2012-06110 FOR A DESCRIPTION OF THE OTHER DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OBTRYX TRANSOBTURATOR MID-URETHRAL SLING SYSTEM WAS IMPLANTED ON (B)(6) 2009. ACCORDING TO THE COMPLAINANT, POST-PROCEDURE, THE PATIENT EXPERIENCED URINARY RETENTION, FREQUENCY, VAGINAL SCARRING, NOCTURIA, RECURRENT URINARY TRACT INFECTIONS, DYSPAREUNIA, VAGINAL PAIN, WORSENING INCONTINENCE AND PELVIC PAIN. ALL OTHER INFORMATION IS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OBTRYX SYSTEM | MESH, SURGICAL, POLYMERIC | FTL | BOSTON SCIENTIFIC - MARLBOROUGH | M0068505000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | PINNACLE ANTERIOR APICAL PELVIC FLOOR REPAIR KIT |