FDA Adverse Event
Injury
Summary report: N
MINIARC SLING SYSTEMS
MDR report key: 1903491
·
Received November 16, 2010
Report
- Report Number
- 2183959-2010-00427
- Event Type
- Injury
- Date Received
- November 16, 2010
- Report Date
- October 18, 2010
- Manufacturer
- AMERICAN MEDICAL SYSTEMS, INC.
- Product Code
- FTL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
INFO FROM A WEB SITE STATED, "I HAD THE MINI ARC SURGERY WITH A VAGINAL HYSTERECTOMY ON (B)(6) 2008. NOW, JUST OVER 2 YEARS LATER, MY INCONTINENCE IS BACK AND WORSE THAN BEFORE. NOW I LEAK BIG TIME, BUT SEEMS LIKE I'M NOT EVEN AWARE OF IT WHEN IT HAPPENS. BEFORE I WOULD PEE MYSELF SOME IF I HAD THE URGE TO GO, NOW I DISCOVER IT AFTER THE FACT AS IT SEEMS I HAVE NO SENSATION AT THE TIME IT HAPPENS. HAS ANYONE ELSE HAD THEIR MINI ARC SURGERY NOT "HOLD"?"
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MINIARC SLING SYSTEMS | SURGICAL MESH | FTL | AMERICAN MEDICAL SYSTEMS, INC. | NI | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Disability | HYSTERECTOMY |