FDA Adverse Event
Injury
Summary report: N
SPARC SLING SYSTEM
MDR report key: 2091474
·
Received May 5, 2011
Report
- Report Number
- 2183959-2011-00154
- Event Type
- Injury
- Date Received
- May 5, 2011
- Date of Event
- February 23, 2009
- Report Date
- April 22, 2011
- Manufacturer
- AMERICAN MEDICAL SYSTEMS, INC.
- Product Code
- FTL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, 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
ON (B)(6) 2009, A SPARC SLING WAS IMPLANTED. BETWEEN (B)(6) 2009-(B)(6) 2011, THE PATIENT WAS SYMPTOMATIC OF "CONTINOUS DRAINAGE FROM SINUS TRACT." THE RIGHT SIDE OF THE SLING WAS "REMOVED." BY REPORT,THE PATIENT IS A FREQUENT HOT TUB USER AND THE TREATING INFECTIOUS DISEASE, DOCTOR QUESTIONS IF THE INFECTION MAY HAVE BEEN FROM THE HOT TUB. THE RIGHT SIDE OF THE SLING WAS CULTURED ON REMOVAL AND WAS POSITIVE FOR (B)(6). THE PATIENT HAS BEGUN "LEAKING AGAIN" AND WOULD LIKE ANOTHER SLING DEVICE IMPLANTED. HER TREATING PHYSICIAN IS "NOT COMFORTABLE DOING THAT."
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 | Required Intervention| S |