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U.S. Department of Health and Human Services

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

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ETHICON INC. PHYSIOMESH OVAL MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number PHY1015V
Device Problem Failure To Adhere Or Bond (1031)
Patient Problems Hernia (2240); No Code Available (3191)
Event Date 11/10/2015
Event Type  Injury  
Manufacturer Narrative
(b)(4). To date, the device has not been returned. If the product is returned for evaluation, any further info derived from the evaluation will be submitted in a supplemental 3500a form.
 
Event Description
It was reported that a patient underwent a ventral hernia repair procedure on an unknown date and mesh was implanted. The patient underwent a reoperation for a recurrent hernia and the surgeon removed the mesh. During the re-operation, the doctor noticed that the mesh was completely unfixed in the patient and essentially balled up. The surgeon opines that they coating on both sides of the mesh is inhibiting tissue in growth. The procedure was completed using a different type of mesh. Additional information was requested.
 
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Brand NamePHYSIOMESH OVAL
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
Manufacturer (Section G)
ETHICON INC.-GMBH
robert-koch strasse 1
norderstedt D-228 51
GM D-22851
Manufacturer Contact
guillermo villa
route 22 west po box 151
somerville, NJ 08876
9082180707
MDR Report Key5250319
MDR Text Key32128962
Report Number2210968-2015-19157
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K093932
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 11/11/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/25/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberPHY1015V
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/10/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/25/2015 Patient Sequence Number: 1
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