FDA Adverse Event
Injury
Summary report: N
PELVICOL 2CM X 7 CM 1.0MM
MDR report key: 3109177
·
Received May 2, 2013
Report
- Report Number
- 9617613-2013-00206
- Event Type
- Injury
- Date Received
- May 2, 2013
- Date of Event
- June 19, 2009
- Report Date
- May 4, 2018
- Manufacturer
- COVIDIEN, TISSUE SCIENCE LABORATORIES, PLC
- 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).
Description of Event or Problem · 1
PROCEDURE TYPE: UROGYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 191102 | PELVICOL 2CM X 7 CM 1.0MM | PELVICOL MESH | FTL | COVIDIEN, TISSUE SCIENCE LABORATORIES, PLC | 08B19-9 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | Other |