FDA Adverse Event
Injury
Summary report: N
PARIETEX ANAT RT PY 16X12CM W FLAPX1
MDR report key: 3131353
·
Received May 20, 2013
Report
- Report Number
- 9615742-2013-00471
- Event Type
- Injury
- Date Received
- May 20, 2013
- Report Date
- April 25, 2013
- Manufacturer
- SOFRADIM PRODUCTION
- Product Code
- FTL
- PMA / PMN Number
- K982532
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
ACCORDING TO THE REPORTER: THE MESH WAS IMPLANTED OVER A YEAR AGO. THE PT LIVED IN A HOUSE WITH BLACK MOLD. THE PHYSICIAN REPORTED A SEVERE REACTION. THE PT IS BEING TREATED FOR THIS REACTION. THE PHYSICIAN SAID THAT THE PT WAS NOT HAVING ANY ISSUES DIRECTLY RELATED TO THE MESH PLACEMENT. THE PHYSICIAN REQUESTED THE EXACT COMPOSITION OF THE MESH IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 222979 | PARIETEX ANAT RT PY 16X12CM W FLAPX1 | PARIETEX ANATOMICAL MESH | FTL | SOFRADIM PRODUCTION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |