FDA Adverse Event
Injury
Summary report: N
PARIETEX UGYTEX PP 15X10CM X1
MDR report key: 3232223
·
Received July 8, 2013
Report
- Report Number
- 9615742-2013-00740
- Event Type
- Injury
- Date Received
- July 8, 2013
- Date of Event
- May 3, 2006
- Report Date
- June 12, 2013
- Manufacturer
- SOFRADIM PRODUCTION
- Product Code
- FTL
- PMA / PMN Number
- K033376
- 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). COVIDIEN IS SUBMITTING THIS REPORT ON BEHALF OF (B)(4) (IMPORTER).
Description of Event or Problem · 1
PROCEDURE: UROGYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. PELVITEX POLYPROPYLENE MESH AND BOSTON SCIENTIFIC OBTRYX HALO SYSTEM WERE REPORTED TO BE USED/ IMPLANTED DURING THIS PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 309090 | PARIETEX UGYTEX PP 15X10CM X1 | PELVITEX MESH | FTL | SOFRADIM PRODUCTION | P24253G3 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Other | UGY1510 PARIETEX UGYTEX PP 15X10CM X1 LOT NUMBER P24253G3, EXP DATE 09/30/2009, MFR DATE 09/2004 |