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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. ETHICON PHYSIOMESH OPEN MESH, SURGICAL, POLYMERIC

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ETHICON INC. ETHICON PHYSIOMESH OPEN MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number OPHY1215
Device Problem Hole In Material (1293)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/11/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). 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.

 
Event Description

It was reported that the patient underwent hiatal hernia repair on (b)(6) 2018 and mesh was used. While the surgeon was placing the mesh into place, two small tears appeared in the middle. The surgeon applied an additional 10x10 mesh over the torn area and the procedure was completed. There were no adverse patient consequences reported. No additional information was provided.

 
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Brand NameETHICON PHYSIOMESH OPEN
Type of DeviceMESH, SURGICAL, POLYMERIC
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
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville 08876-0151
9082182792
MDR Report Key7213296
MDR Text Key98051202
Report Number2210968-2018-70415
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK141560
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 01/12/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/23/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberOPHY1215
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/12/2018
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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