FDA Adverse Event
Injury
Summary report: N
PELVICOL (BARD) 8CM X 12CM
MDR report key: 2990040
·
Received February 14, 2013
Report
- Report Number
- 9617613-2013-00033
- Event Type
- Injury
- Date Received
- February 14, 2013
- Date of Event
- February 18, 2003
- Report Date
- May 4, 2018
- 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
- ATTORNEY
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: UROGYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEICE. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. ADD'L INFO FROM IMPORTER REPORT 1018233-2013-00408: THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADD'L INFO HAS BEEN REQUESTED, BUT NOT RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 65377 | PELVICOL (BARD) 8CM X 12CM | PELVICOL MESH | FTL | COVIDIENT, FORMERLY TISSUE SCIENCE | NA | 02A30 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Female | Other | BOSTON SCIENTIFIC PRODUCT: PRECISION TWIST ANCHOR- | SYSTEM| SYSTEM| BOSTON SCIENTIFIC PRODUCT: PRECISION TWIST ANCHOR- |