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U.S. Department of Health and Human Services

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

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ETHICON INC. PHYSIOMESH MESH, SURGICAL Back to Search Results
Catalog Number PHY1515Q
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Nausea (1970); Pain (1994); Hernia (2240); Abdominal Distention (2601); Not Applicable (3189)
Event Type  Injury  
Manufacturer Narrative
(b)(4). To date, the device has not been returned. If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.
 
Event Description
It was reported by an attorney that the patient underwent a hernia repair procedure on (b)(6) 2011 and mesh was implanted. It was reported that the patient underwent a hernia repair procedure on (b)(6) 2012 and mesh was implanted. It was reported the patient experienced an undisclosed adverse event. No additional information was provided.
 
Manufacturer Narrative
Date sent to fda: 12/13/2019.
 
Manufacturer Narrative
Date sent to fda: 1/2/2020. Additional narrative: it was reported that patient underwent removal of mesh on (b)(6) 2016 due to recurrent hernia and adhesion.
 
Manufacturer Narrative
Date sent to fda: 4/20/2020. Additional narrative: it was reported that following insertion the patient experienced pain, nausea, bloating, constipation, bulging and abdominal wall mass.
 
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Brand NamePHYSIOMESH
Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
MDR Report Key8205488
MDR Text Key131702659
Report Number2210968-2018-77792
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K093932
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup,Followup,Followup
Report Date 12/31/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberPHY1515Q
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/19/2020
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 12/30/2018 Patient Sequence Number: 1
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