FDA Adverse Event
Injury
Summary report: N
PARIETEX COMP 20X15CM OS VERSION X1
MDR report key: 4241312
·
Received November 10, 2014
Report
- Report Number
- 9615742-2014-00334
- Event Type
- Injury
- Date Received
- November 10, 2014
- Date of Event
- April 1, 2011
- Report Date
- October 27, 2014
- Manufacturer
- SOFRADIM PRODUCTION
- Product Code
- FTL
- PMA / PMN Number
- K040998
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PREOPERATIVE DIAGNOSIS:CHRONICALLY INFECTED ABDOMINAL MESH.POSTOPERATIVE DIAGNOSIS:CHRONICALLY INFECTED ABDOMINAL MESH, MULTIPLE SMALL BOWEL FISTULAE/ENTEROTOMIES NOT ADEQUATELY CONTROLLED AND HEMORRHAGIC SHOCK.PATIENT WAS ADMITTED 4/1/2011 FOR THE REPAIR OF A VENTRAL HERNIA. THE HERNIA WAS REPAIRED WITH PARIETEX COMPOSITE MESH (PCO2015OS). ON (B)(6) 2014 THE PATIENT UNDERWENT A RE-OPERATION FOR THE EXCISION OF THE MESH WHICH HAD BECOME INFECTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 723532 | PARIETEX COMP 20X15CM OS VERSION X1 | PARIETEX COMP | FTL | SOFRADIM PRODUCTION | PCO2015OS | PIJ00229 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Other |