FDA Adverse Event
Injury
Summary report: N
AMS SURGICAL MESH
MDR report key: 2770344
·
Received October 1, 2012
Report
- Report Number
- 2183959-2012-02820
- 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
- LA, US
- Reporter Occupation
- NOT APPLICABLE
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 THAT THE PT HAD AN AMS SLING IMPLANTED, THE DATE OF IMPLANT AND PRODUCT WERE NOT PROVIDED. FOLLOWING THE IMPLANT THE PT HAD INCONTINENCE THAT WAS MORE THAN BASELINE. ANOTHER CONTINENCE DEVICE WAS IMPLANTED ON (B)(6) 2012. THE PT'S OUTCOME WAS REPORTED TO BE "PERFECT" WITH "RARE LEAKAGE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AMS SURGICAL MESH | SURGICAL MESH | FTL | AMERICAN MEDICAL SYSTEMS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Disability |