FDA Adverse Event
Injury
Summary report: N
PELVICOL ACELLULAR COLLIGEN MATRIX
MDR report key: 3439608
·
Received October 17, 2013
Report
- Report Number
- 9617613-2013-01208
- Event Type
- Injury
- Date Received
- October 17, 2013
- Date of Event
- December 28, 2005
- Report Date
- September 26, 2013
- Manufacturer
- COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES
- Product Code
- FTL
- PMA / PMN Number
- K992556
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). COVIDIEN IS SUBMITTING THIS REPORT ON BEHALF OF (B)(4), (IMPORTER). (B)(4).
Additional Manufacturer Narrative · 1
TRACKING NUMBER (B)(4). INITIAL REPORT SENT TO FDA ON (B)(4) 2013. EXEMPTION NUMBER: (B)(4). COVIDIEN IS SUBMITTING THIS REPORT ON BEHALF OF (B)(4). BARD'S TRACKING NUMBER: (B)(4).
Description of Event or Problem · 1
PROCEDURE: UROGYNECOLOGICAL. ACCORDING TO THE REPORTER; THE PT ALLEGED INJURY.
Description of Event or Problem · 1
PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED PAIN, EROSION, EXTRUSION, INFECTION, UNSPECIFIED URINARY PROBLEMS, RECURRENCE, BLEEDING, DYSPAREUNIA, AND VAGINAL SCARRING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 532644 | PELVICOL ACELLULAR COLLIGEN MATRIX | PELVICOL MESH | FTL | COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES | 04B20-1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Other |