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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. ETHICON PHYSIOMESH COMPOSITE MESH 30X35CM RECT MESH, SURGICAL, POLYMERIC

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ETHICON INC. ETHICON PHYSIOMESH COMPOSITE MESH 30X35CM RECT MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number PHY3035R
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Injury (2348); 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) 2014 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: 3/05/2019. Additional narrative: it was reported that following the procedure, patient had a removal surgery on (b)(6) 2017 due to abscess. In addition, a review of the manufacturing records was performed and indicates that there were no quality concerns associated with the manufacturing process.
 
Manufacturer Narrative
Date sent to fda: 6/29/2020.
 
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Brand NameETHICON PHYSIOMESH COMPOSITE MESH 30X35CM RECT
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
MDR Report Key8196907
MDR Text Key131419296
Report Number2210968-2018-77757
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K962530
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup,Followup
Report Date 02/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/30/2015
Device Catalogue NumberPHY3035R
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/26/2020
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 12/26/2018 Patient Sequence Number: 1
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