FDA Adverse Event
Injury
Summary report: N
SPARC SLING SYSTEM
MDR report key: 3010298
·
Received March 12, 2013
Report
- Report Number
- 2183959-2013-00749
- Event Type
- Injury
- Date Received
- March 12, 2013
- Date of Event
- February 27, 2013
- Report Date
- February 28, 2013
- Manufacturer
- AMERICAN MEDICAL SYSTEMS, INC.
- Product Code
- FTL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE REGARDING THIS EVENT, IT WILL BE RE-EVALUATED AND A FOLLOW-UP REPORT WILL BE SENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT A SPARC WAS IMPLANTED SOMETIME IN 2011 FOR TREATMENT OF URINARY INCONTINENCE. INFORMATION RECEIVED INDICATES A CONCOMITANT HYSTERECTOMY PROCEDURE DURING THE INITIAL IMPLANT. INFORMATION PROVIDED INDICATES THAT THE PATIENT EXPERIENCED RECURRENT INCONTINENCE AND ON (B)(6) 2013 4MM MESH EXTRUSION INTO THE VAGINA WAS REMOVED AND A SECOND SLING IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 104597 | SPARC SLING SYSTEM | SURGICAL MESH | FTL | AMERICAN MEDICAL SYSTEMS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |