FDA Adverse Event
Injury
Summary report: N
SPARC SLING SYSTEM
MDR report key: 2770356
·
Received October 1, 2012
Report
- Report Number
- 2183959-2012-02811
- Event Type
- Injury
- Date Received
- October 1, 2012
- Report Date
- September 18, 2012
- Manufacturer
- AMERICAN MEDICAL SYSTEMS, INC.
- Product Code
- FTL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
SHOULD ADD'L INFO BECOME AVAILABLE REGARDING THIS EVENT, IT WILL BE RE-EVALUATED AND A F/U REPORT WILL BE SENT.
Description of Event or Problem · 1
IT WAS REPORTED BY THE JOURNAL OF THE BRAZILIAN SOCIETY OF UROLOGY THAT A PT WAS IMPLANTED WITH A SPARC SLING IN/AROUND 2010 TO TREAT STRESS URINARY INCONTINENCE. IT IS REPORTED THAT THE PT EXPERIENCED SEVERAL EPISODES OF URINARY TRACT INFECTIONS STARTING ONE WEEK AFTER SURGERY. PT EXPERIENCED VOIDING URETHRAL PAIN, FREQUENCY, AND HEMATURIA. THE PT UNDERWENT A CYSTOSCOPY WHICH REVEALED THE MISPLACEMENT MESH WITH STONE ENCRUSTATION, WHICH WAS REMOVED BY THULIUM LASER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPARC SLING SYSTEM | SURGICAL MESH | FTL | AMERICAN MEDICAL SYSTEMS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R| S |