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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON PHYSIOMESH FLEXIBLE COMPOSITE MESH

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ETHICON PHYSIOMESH FLEXIBLE COMPOSITE MESH Back to Search Results
Model Number PHY1015
Device Problems Nonstandard Device (1420); Device Operates Differently Than Expected (2913)
Patient Problem Therapeutic Effects, Unexpected (2099)
Event Date 12/28/2011
Event Type  Malfunction  
Event Description

Original hernia repair conducted with product that has now voluntarily been recalled by the manufacturer due to greater than expected recurrence/operative rates. Pt required a second procedure due to recurrent hernia.

 
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Brand NamePHYSIOMESH FLEXIBLE COMPOSITE MESH
Type of DevicePHYSIOMESH FLEXIBLE COMPOSITE MESH
Manufacturer (Section D)
ETHICON
somerville NJ 08876
MDR Report Key5754548
MDR Text Key48444563
Report NumberMW5063088
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 06/23/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/23/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/01/2013
Device MODEL NumberPHY1015
Device LOT NumberDK8KGA0RH
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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