FDA Adverse Event
Injury
Summary report: N
PELVICOL ACELLULAR AOLLAGEN MATRIX 4X7M
MDR report key: 3231937
·
Received July 11, 2013
Report
- Report Number
- 9617613-2013-00488
- Event Type
- Injury
- Date Received
- July 11, 2013
- Date of Event
- January 26, 2006
- Report Date
- May 7, 2018
- Manufacturer
- COVIDIEN
- Product Code
- FTL
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
TRACKING NUMBER: (B)(4).
Description of Event or Problem · 1
PROCEDURE: STRESS UI/PELVIC ORGAN PROLAPSE. ACCORDING TO THE REPORTER: THE PATIENT ALLEGED INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 319973 | PELVICOL ACELLULAR AOLLAGEN MATRIX 4X7M | PELVICOL MESH | FTL | COVIDIEN | 04B23-9 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Female | Other |