FDA Adverse Event
Injury
Summary report: N
PARIETEX UGUREX PP 15X10CM X1
MDR report key: 2963141
·
Received January 31, 2013
Report
- Report Number
- 9615742-2013-00044
- Event Type
- Injury
- Date Received
- January 31, 2013
- Date of Event
- November 23, 2009
- Report Date
- January 3, 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
(B)(4)
Description of Event or Problem · 1
PROCEDURE TYPE: UROGYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFO HAS BEEN REQUESTED, BUT NOT YET RECEIVED. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. ADDITIONAL INFO FROM IMPORTER REPORT: ASSOCIATED MDR: 1018233-2013-00196.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 42519 | PARIETEX UGUREX PP 15X10CM X1 | PELVITEX MESH | FTL | SOFRADIM PRODUCTION | NA | PJC00738 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Female | Required Intervention| O | ALIGN R RETROPUBIC URETHRAL SUPPORT SYSTEM| ALIGN R RETROPUBIC URETHRAL SUPPORT SYSTEM |