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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 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
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) 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: 07/13/2020.Additional h6 patient codes: 3189 - surgical intervention.Additional information: a1, a2, b2.B7, d7.Additional b5 narrative: details: it was reported that the patient experienced recurrent ventral hernia, lysis of adhesions, and pain.It was reported that the patient underwent a mesh removal on (b)(6)2013.
 
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Brand Name
PHYSIOMESH UNKNOWN PRODUCT
Type of Device
MESH, SURGICAL
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876
MDR Report Key10014632
MDR Text Key189607174
Report Number2210968-2020-03619
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
Report Date 04/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received07/10/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age41 YR
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