FDA Adverse Event
Malfunction
Summary report: N
PCO VENTRAL PATCH 4C
MDR report key: 4637653
·
Received March 27, 2015
Report
- Report Number
- 9615742-2015-00018
- Event Type
- Malfunction
- Date Received
- March 27, 2015
- Date of Event
- March 3, 2015
- Report Date
- March 5, 2015
- Manufacturer
- SOFRADIM PRODUCTION
- Product Code
- OXJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SF
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE: HERNIA REPAIR. ACCORDING TO THE REPORTER, THE MESH WOULD NOT DEPLOY. IT WOULD FOLD ONTO ITSELF. THE SURGEON TRIED THREE TIMES TO PLACE AND WAS UNABLE TO FIXATE IT. THE SURGICAL TIME WAS EXTENDED BY 15 MIN. SAMPLE WILL NOT BE RETURNED FOR INVESTIGATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 205722 | PCO VENTRAL PATCH 4C | MESH | OXJ | SOFRADIM PRODUCTION | PCO4VP | PNL0168 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR |