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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOHNSON & JOHNSON INTERNATIONAL ETHICON PHYSIOMESH COMPOSITE MESH 15X20CM RECT MESH, SURGICAL

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JOHNSON & JOHNSON INTERNATIONAL ETHICON PHYSIOMESH COMPOSITE MESH 15X20CM RECT MESH, SURGICAL Back to Search Results
Catalog Number PHY1520R
Device Problem Failure To Adhere Or Bond (1031)
Patient Problems Adhesion(s) (1695); Unspecified Infection (1930); Pain (1994); Hernia (2240); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative

(b)(4). To date the device has not been returned. If the device or further details are received at a later date a supplemental medwatch will be sent.

 
Event Description

It was reported by an attorney that the patient had mesh implanted laparoscopically to repair a ventral hernia on (b)(6) 2011. On (b)(6) 2013, the patient had to undergo a revision surgery due to complications. She was found to have infected mesh which was loose and not incorporated into the anterior abdominal wall, recurrent hernia, pain, with adhesion complications. No additional information was provided.

 
Manufacturer Narrative

In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria. ,.

 
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Brand NameETHICON PHYSIOMESH COMPOSITE MESH 15X20CM RECT
Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
JOHNSON & JOHNSON INTERNATIONAL
leonardo da vincilaan 15
diegem 1831
BE 1831
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, NJ 08876-0151
9082182792
MDR Report Key6642874
MDR Text Key77623504
Report Number2210968-2017-60270
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK093932
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/15/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/15/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/30/2013
Device Catalogue NumberPHY1520R
Device LOT NumberDH8JGBA0
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 Received03/05/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/01/2011
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: 06/15/2017 Patient Sequence Number: 1
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