FDA Adverse Event
Injury
Summary report: N
PELVICOL ACELLULAR COLLIGEN MATRIX
MDR report key: 2901192
·
Received November 7, 2012
Report
- Report Number
- 9617613-2012-00227
- Event Type
- Injury
- Date Received
- November 7, 2012
- Date of Event
- September 24, 2003
- Report Date
- October 10, 2012
- Manufacturer
- COVIDIENT, FORMERLY TISSUE SCIENCE
- 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
(B)(4). DATE OF REPORT: (B)(4) 2012, DEVICE MFR: TISSUE SCIENCE LABS, (B)(4). (B)(6).
Description of Event or Problem · 1
PROCEDURE: UROLOGICAL / GYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PT UNDERWENT A REPAIR PROCEDURE AND THE PT ALLEGEDLY EXPERIENCED PAIN AND INJURY. PT HAS UNDERGONE OR WILL UNDERGO CORRECTIVE SURGERY OR SURGERIES. IT WAS REPORTED BY THE PT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PT HAS EXPERIENCED INJURIES, INFECTIONS, PAIN, DISCHARGE AND HAS HAD MULTIPLE CORRECTIVE SURGERIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PELVICOL ACELLULAR COLLIGEN MATRIX | PELVICOL MESH | FTL | COVIDIENT, FORMERLY TISSUE SCIENCE | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | Female | Required Intervention| O | PRECISION TWIST TRANSVAGINAL ANCHOR SYSTEM| PRECISION TWIST TRANSVAGINAL ANCHOR SYSTEM |