FDA Adverse Event
Injury
Summary report: N
PELVICOL 2CM X 7CM 1.0MM
MDR report key: 3131450
·
Received May 10, 2013
Report
- Report Number
- 9617613-2013-00231
- Event Type
- Injury
- Date Received
- May 10, 2013
- Date of Event
- February 6, 2008
- Report Date
- April 12, 2013
- Manufacturer
- COVIDIEN, FORMERLY TISSUE
- Product Code
- FTL
- PMA / PMN Number
- K992556
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: UROGYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PRODUCE WAS USED FOR THERAPEUTIC TREATMENT.
Description of Event or Problem · 1
ON (B)(6) 2008: 2 MM ERODED TVT MATERIAL BACK ON THE LEFT SIDE - RECOMMENDED SLING REVISION UNDER ANESTHESIA. MESH REVISION SURGERY: (B)(6) 2008: UNDERWENT FIRST SLING REVISION SURGERY FOR EROSION OF TVT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 209366 | PELVICOL 2CM X 7CM 1.0MM | PELVICOL MESH | FTL | COVIDIEN, FORMERLY TISSUE | 07B03-9 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Other |