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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 UMM1
Device Problems Hole In Material (1293); Appropriate Term/Code Not Available (3191)
Patient Problems Hernia (2240); No Code Available (3191)
Event Date 11/23/2016
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 right inguinal hernia repair procedure on unknown date more than one year ago and the mesh was implanted using a liechtenstein technique. It was also reported that during a second surgery, the mesh was found ruptured in two halves/parts. One half of the mesh was fixed and integrated to oblique minor and the other half was in strip and between both there was a recurrent hernia. The surgeon opined that the alleged product failure is manifested during the second surgical intervention due to re-occurrence and one year of placement evidences the state of the recidivism/relapse, the rupture of the mesh and the conservation, still of the ambirisable material. 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 Key6178803
MDR Text Key62520001
Report Number2210968-2016-60108
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeAR
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 11/30/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUMM1
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 Received11/25/2016
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: 12/15/2016 Patient Sequence Number: 1
Treatment
3-0PROLENE SUTURE
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