FDA Adverse Event
Injury
Summary report: N
PELVICOL ACELLULAR COLLAGEN MATRIX 4X7CM
MDR report key: 3232218
·
Received July 8, 2013
Report
- Report Number
- 9617613-2013-00483
- Event Type
- Injury
- Date Received
- July 8, 2013
- Date of Event
- August 9, 2007
- Report Date
- June 13, 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
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
TRACKING NUMBER (B)(4)2013003. COVIDIEN IS SUBMITTING THIS REPORT ON BEHALF OF (B)(4) (IMPORTER). .
Description of Event or Problem · 1
PROCEDURE: STRESS UI/ PELVIC ORGAN PROLAPSE. ACCORDING TO THE REPORTER: AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED INFECTIONS, PAIN, MENTAL ANGUISH, DISCHARGE AND MULTIPLE CORRECTIVE SURGERIES. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. AVAULTA SOLO POSTERIOR SYNTHETIC SUPPORT SYSTEM WAS REPORTED TO BE USED/ IMPLANTED DURING THIS PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 308703 | PELVICOL ACELLULAR COLLAGEN MATRIX 4X7CM | PELVICOL MESH | FTL | COVIDIEN, FORMERLY TISSUE | 06B18-0 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Female | Required Intervention| O |