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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOHNSON & JOHNSON INTERNATIONAL ULTRAPRO MESH MESH, SURGICAL, POLYMERIC

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JOHNSON & JOHNSON INTERNATIONAL ULTRAPRO MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number UML1
Device Problem Hole In Material (1293)
Patient Problems Hernia (2240); No Code Available (3191)
Event Date 10/18/2016
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 that the patient underwent a hernia repair procedure ten years ago and the mesh was implanted. Recently, a few days ago, the patient visited a doctor to present a recurrent hernia. During reoperation, it was found that the mesh was broken and the surgeon made a repair of abdominal wall. No further information is available.
 
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Brand NameULTRAPRO MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
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
krystina laguna
route 22 westp o box 151
somerville, NJ 08876
9082183043
MDR Report Key6078424
MDR Text Key59132269
Report Number2210968-2016-60070
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeBU
PMA/PMN Number
K033337
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 10/19/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/04/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUML1
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 Received10/18/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 11/04/2016 Patient Sequence Number: 1
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