FDA Adverse Event
Injury
Summary report: N
PELVICOL ACELLULAR COLLIGEN MARTRIX
MDR report key: 3231941
·
Received July 11, 2013
Report
- Report Number
- 9617613-2013-00492
- Event Type
- Injury
- Date Received
- July 11, 2013
- Date of Event
- October 21, 2004
- Report Date
- November 16, 2024
- Manufacturer
- COVIDIEN
- Product Code
- FTL
- PMA / PMN Number
- K992556
- 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: UROGYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PATIENT ALLEGED INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 321190 | PELVICOL ACELLULAR COLLIGEN MARTRIX | PELVICOL MESH | FTL | COVIDIEN | 03B18-2 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | Female | Other |