FDA Adverse Event
Injury
Summary report: N
SPARC SLING SYSTEMS
MDR report key: 1241532
·
Received November 21, 2008
Report
- Report Number
- 2183959-2008-00025
- Event Type
- Injury
- Date Received
- November 21, 2008
- Date of Event
- September 7, 2006
- Report Date
- November 21, 2008
- Manufacturer
- AMERICAN MEDICAL SYSTEMS, INC.
- Product Code
- FTL
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
AMS RECEIVED INFORMATION ABOUT A PATIENT WHO WAS IMPLANTED WITH SPARC SLING WAS ADMITTED FOR OUTPATIENT REPAIR OF STRESS URINARY INCONTINENCE IN 2006. EXPERIENCED BLOODY URINE AND URINARY RETENTION POSTOPERATIVE DISCHARGED TWO DAYS LATER WITH FOLEY CATHETER IN PLACE. A MONTH LATER, PATIENT FOUND TO HAVE 2CM OF MESH PENETRATING AND PERFORATING THE BLADDER THAT REQUIRED MULTIPLE SURGICAL PROCEDURES AND SUFFERED FROM CHRONIC HEMATURIA AND UTI THROUGH 2008.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPARC SLING SYSTEMS | SPARC/OTHER SLING TYPES | FTL | AMERICAN MEDICAL SYSTEMS, INC. | 72403656 | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Hospitalization| R |