MalfunctionOXJ
PCO VENTRAL PATCH 4C
Received Mar 27, 2015 · Event occurred Mar 3, 2015
Report 9615742-2015-00018 · MDR key 4637653
Device
Generic name
Mesh
Manufacturer
Sofradim ProductionModel number
PCO4VPCatalog number
PCO4VP
Lot number
PNL0168
Product problems
- Positioning Failure
- Folded
Patient
51 YR
- No Information
Narrative
Description of Event or Problem
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.
Additional Manufacturer Narrative
(B)(4).
Additional Manufacturer Narrative
(B)(4).