FDA Adverse Event
Malfunction
Summary report: N
LYNX
MDR report key: 2202196
·
Received August 5, 2011
Report
- Report Number
- MW5021682
- Event Type
- Malfunction
- Date Received
- August 5, 2011
- Date of Event
- January 30, 2009
- Report Date
- August 5, 2011
- Manufacturer
- BOSTON SCIENTIFIC
- Product Code
- FTL
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- LA, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
I UNDERWENT THE S.U.I. SURGERY IN WHICH THEY IMPLANTED THE LYNX MID URETHRAL PUBOVAGINAL SLING ON (B)(6) 2009. NOW I HAVE MORE SERIOUS PROBLEMS WITH MY BLADDER. I HAVE EXPERIENCED THE FOLLOWING: BLADDER PAINS, BLADDER INFECTIONS, PAIN DURING SEXUAL INTERCOURSE, AND MY LEGS SOMETIMES GET NUMB. I HAVE BEEN TO THE DOCTOR FOR MY PROBLEMS WITH MY BLADDER, BUT ALL HE DID WAS PRESCRIBE PAIN MEDICATION. I HAVE BEEN IN CONSTANT PAIN EVERYDAY SINCE THE SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LYNX | SLING | FTL | BOSTON SCIENTIFIC | UNKNO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR |