FDA Adverse Event
Injury
Summary report: N
REMEEX SYSTEM FOR URINARY INCONTINENCE
MDR report key: 2468843
·
Received February 22, 2012
Report
- Report Number
- 3006621295-2012-00001
- Event Type
- Injury
- Date Received
- February 22, 2012
- Date of Event
- January 10, 2012
- Report Date
- February 20, 2012
- Manufacturer
- DIMA S.L.
- Product Code
- FTL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
WE HAVE CONTACTED TO THE INITIAL REPORTER (B)(6). DUE TO HOSPITAL POLICIES AND REGULATIONS, SHE IS UNABLE TO ANSWER ANY OF THE QUESTION - INCLUDING SUPPLYING THE SURGEON'S INFO OR ANY INFO PT RELATED. TO THE QUESTION REGARDING THE HEALTH OF THE PT, SHE DID SAY THE PT IS DOING OK.
Description of Event or Problem · 1
PT HAD IMPLANTATION OF MID URETHRAL SLING APPROX 2 YEARS AGO PREDOMINANTLY FOR STRESS INCONTINENCE AND INTRINSIC SPHINCTER DEFICIENCY. APPROX 7 MONTHS FOLLOWING THE PROCEDURE, PT EXPERIENCED 0.5 CM OF EXPOSED WHITE MESH DIRECTLY BEHIND URETHRAL MEATUS. DUE TO CONTINUED MESH EROSION, PT RECENTLY RETURNED TO SURGERY FOR "REMOVAL OF MID URETHRAL SLING CONTASURE REMEEX SLING AND CONTROLLER BOX".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REMEEX SYSTEM FOR URINARY INCONTINENCE | VAGINAL SLING | FTL | DIMA S.L. | CRSF 20090330 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Hospitalization| R |