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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON ETHICON PHYSIOMESH ETHICON HERNIA MESH

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ETHICON ETHICON PHYSIOMESH ETHICON HERNIA MESH Back to Search Results
Model Number PHY 1520V
Event Date 04/15/2011
Event Type  Malfunction  
Event Description

Laparoscopic ventral hernia repair with ethicon mesh. Mesh pulled away from abdominal wall resulting in 2nd surgery laparoscopic & open (laparotomy) removal of mesh, repair of recurrent ventral hernia using bard mesh.

 
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Brand NameETHICON PHYSIOMESH
Type of DeviceETHICON HERNIA MESH
Manufacturer (Section D)
ETHICON
route 22 west
somerville NJ 08876 015
MDR Report Key2069574
Report Number2069574
Device Sequence Number1
Product CodeFTL
Report Source User Facility
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 04/19/2011
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/19/2011
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator INVALID DATA
Device MODEL NumberPHY 1520V
Device LOT NumberCH9CS220
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/19/2011
Event Location Hospital

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