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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PHYSIOMESH UNKNOWN PRODUCT MESH, SURGICAL

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ETHICON INC. PHYSIOMESH UNKNOWN PRODUCT MESH, SURGICAL Back to Search Results
Device Problem Hole In Material (1293)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/01/2016
Event Type  Malfunction  
Manufacturer Narrative

To date the device has not been returned. If the device or further details are received at a later date a supplemental medwatch will be sent. Additional information was requested and the following was obtained: please confirm product code and lot#. The information on submitted is all available information. This was learned through a surgeon attending a conference.

 
Event Description

It was reported that the patient underwent a hernia repair procedure on an unknown date approximately 12 months ago and mesh was used. During the procedure, suture was used to fixate the mesh and the suture pulled through the mesh. The procedure was completed with a like device. There were no adverse patient consequences reported. No additional information was provided.

 
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Brand NamePHYSIOMESH UNKNOWN PRODUCT
Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville 08876 0151
Manufacturer (Section G)
ETHICON GMBH
p.o. box 1409 d22841
norderstedt
GM
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville 08876-0151
9082182792
MDR Report Key6985119
MDR Text Key91089787
Report Number2210968-2017-70681
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUK
PMA/PMN NumberK093932
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 10/01/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/27/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/01/2017
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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