FDA Adverse Event
Other
Summary report: N
PARIETEX UGYTEX PP ANTERIOR KIT X1
MDR report key: 2794077
·
Received September 28, 2012
Report
- Report Number
- 9615742-2012-00462
- Event Type
- Other
- Date Received
- September 28, 2012
- Date of Event
- August 14, 2006
- Report Date
- August 31, 2012
- Manufacturer
- SOFRADIM PRODUCTION
- Product Code
- FTL
- PMA / PMN Number
- K051503
- 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). NOTE: THIS REPORT CORRESPONDS WITH BARD'S REPORT #(B)(4) FOR AN "AVAULTA ANTERIOR".
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. ADDITIONAL INFORMATION FROM THE IMPORTER REPORT: IT WAS REPORTED BY THE PT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PT HAS EXPERIENCED PAIN, DISABILITY AND IMPAIRMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PARIETEX UGYTEX PP ANTERIOR KIT X1 | AVAULTA ANTERIOR | FTL | SOFRADIM PRODUCTION | NA | ZGB00592 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Female | Required Intervention| O |