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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 PHY1015V
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Pain (1994); Hernia (2240); Discomfort (2330); Injury (2348)
Event Type  Injury  
Manufacturer Narrative
Additional information. Additional patient codes: (b)(4) - surgical intervention device code: (b)(6) -hernia recurrence occurred additional narrative: it was reported that the patient underwent a hernia repair surgery on (b)(6) 2013 and physiomesh was implanted. It was reported that following insertion the patient experienced pain, discomfort and hernia recurrence. It was reported that patient underwent mesh revision on (b)(6) 2014 and on (b)(6) 2017 by (b)(6). No additional information was provided.
 
Manufacturer Narrative
In addition, a device history review has been inserted into the file. This review indicates that there was no quality concerns associated with the manufacturing process.
 
Event Description
It was reported by an attorney that the patient underwent a hernia repair surgery on (b)(6) 2013 and mesh was implanted. It was reported that the patient experienced an undisclosed adverse event. No additional information was provided.
 
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 surgery on (b)(6) 2013 and mesh was implanted.  it was reported that the patient experienced an undisclosed adverse event. No additional information was provided.
 
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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
Manufacturer (Section G)
ETHICON INC.
p.o. box 151, route 22 west
somerville 08876 0151
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville 08876-0151
9082182792
MDR Report Key7153803
MDR Text Key106794491
Report Number2210968-2017-71877
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 other
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/30/2014
Device Catalogue NumberPHY1015V
Device Lot NumberEP8GKTA0
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 Received04/24/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/01/2012
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: 12/29/2017 Patient Sequence Number: 1
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