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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOHNSON & JOHNSON INTERNATIONAL ETHICON PHYSIOMESH COMPOSITE MESH 30X35CM RECT MESH, SURGICAL

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JOHNSON & JOHNSON INTERNATIONAL ETHICON PHYSIOMESH COMPOSITE MESH 30X35CM RECT MESH, SURGICAL Back to Search Results
Catalog Number PHY3035R
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Adhesion(s) (1695); Pain (1994); Hernia (2240); Obstruction/Occlusion (2422); Ambulation Difficulties (2544); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Details: it was reported that the patient underwent a hernia repair surgeries on (b)(6) 2011 and (b)(6) 2014 and physiomesh was implanted during each surgery. It was reported that the patient experienced an undisclosed adverse event.
 
Manufacturer Narrative
Patient code: (b)(4). It was reported that following insertion the patient experienced small-bowel obstruction and adhesion.
 
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.
 
Manufacturer Narrative
(b)(4). To date the device has not been returned. If the device or further details are received at the later date a supplemental medwatch will be sent. This medwatch report is in response to receipt of maude event report mw5067990.
 
Event Description
It was reported that the patient underwent a ventral incisional hernia repair in 2011 and the mesh was used. Six weeks later the patient was sent to pain management due to continuing serious pain. In 2014 the patient was rushed to er due to incarcerated loop of small bowel within ventral hernia and the mesh was replaced with another like mesh on (b)(6) 2014. It was also reported that the patient can barely walk and now diagnosed with psoriatic arthritis. The patient has been on disability since 2012 and had to go to pain management for seven years. Additional information has been requested.
 
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Brand NameETHICON PHYSIOMESH COMPOSITE MESH 30X35CM RECT
Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
JOHNSON & JOHNSON INTERNATIONAL
leonardo da vincilaan 15
diegem 1831
BE 1831
Manufacturer (Section G)
ETHICON INC.-GMBH
robert-koch strasse 1
norderstedt D-228 51
GM D-22851
Manufacturer Contact
darlene kyle
route 22 west po box 151
somerville, NJ 08876
9082182792
MDR Report Key6465145
MDR Text Key106589481
Report Number2210968-2017-60163
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 consumer,other
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 04/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/31/2013
Device Catalogue NumberPHY3035R
Device Lot NumberDD8HHDA0
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 Received04/25/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/04/2011
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: 04/06/2017 Patient Sequence Number: 1
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