FDA Adverse Event
Injury
Summary report: N
ADVANCE MALE SLING SYSTEM
MDR report key: 2842105
·
Received November 13, 2012
Report
- Report Number
- 2183959-2012-03001
- Event Type
- Injury
- Date Received
- November 13, 2012
- Report Date
- October 30, 2012
- Manufacturer
- AMERICAN MEDICAL SYSTEMS, INC.
- Product Code
- FTL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, 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 AN ADVANCE SLING WAS IMPLANTED. DATE OF PROCEDURE WAS NOT AVAILABLE. THE PATIENT EXPERIENCED AN INCREASED LEVEL OF INCONTINENCE AFTER THE SLING IMPLANT. ON (B)(6) 2012, THE PATIENT UNDERWENT AN ADDITIONAL INCONTINENCE DEVICE IMPLANT PROCEDURE DUE TO THE CONTINUED INCONTINENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ADVANCE MALE SLING SYSTEM | SURGICAL MESH | FTL | AMERICAN MEDICAL SYSTEMS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Disability |