FDA Adverse Event
Injury
Summary report: N
SEE H10 COMMENTS
MDR report key: 2200836
·
Received August 8, 2011
Report
- Report Number
- 2183959-2011-00289
- Event Type
- Injury
- Date Received
- August 8, 2011
- Report Date
- June 13, 2011
- Manufacturer
- AMERICAN MEDICAL SYSTEMS, INC.
- Product Code
- FTL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AS OF (B)(6) 2011, THE ALLEGED AMS DEVICE HAS NOT BEEN IDENTIFIED TO-DATE. SHOULD ADD'L INFO BECOMES AVAILABLE REGARDING THIS EVENT IT WILL BE RE-EVALUATED AND A F/U REPORT WILL BE SENT.
Description of Event or Problem · 1
ON ABOUT (B)(6) 2009, IT WAS REPORTED, THE PT UNDERWENT A TRANSVAGINAL TAPE, BLADDER SLING, URETHRAL SUSPENSION AND REVISION OF MESH EROSION. FURTHER, THE PT REPORTS THAT SINCE IMPLANTATION, SHE HAS EXPERIENCED EROSION, SHRINKAGE, EXTRUSION OF THE MESH, URINARY RETENTION, SEVERE AND PERSISTENT PAIN, DYSPAREUNIA, AND "NUMEROUS SURGICAL PROCEDURES TO REMOVE THE MESH DEVICES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SEE H10 COMMENTS | SURGICAL MESH | FTL | AMERICAN MEDICAL SYSTEMS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention| S |