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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 PHY2025V
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Pain (1994); Hernia (2240); Injury (2348)
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) 2010 and mesh was implanted.It was reported the patient experienced an undisclosed adverse event.No additional information was provided.
 
Manufacturer Narrative
Additional h6 patient code: 3189- surgical intervention.Additional b5 narrative: it was reported that the patient underwent mesh removal on (b)(6) 2018 due to adhesions, pain and hernia recurrence.
 
Manufacturer Narrative
Date sent to fda: 4/22/2020.
 
Manufacturer Narrative
A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
 
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Brand Name
PHYSIOMESH
Type of Device
MESH, SURGICAL
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876
MDR Report Key9357063
MDR Text Key181346364
Report Number2210968-2019-90128
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 11/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date08/31/2011
Device Catalogue NumberPHY2025V
Device Lot NumberCJ9LWCZ0
Was Device Available for Evaluation? No
Date Manufacturer Received04/27/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age61 YR
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