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U.S. Department of Health and Human Services

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

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JOHNSON & JOHNSON INTERNATIONAL ULTRAPRO COMFORT PLUG PRODUCT MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number UPLUG551
Device Problem Hole In Material (1293)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/06/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria. Attempts have been made to retrieve the device. 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 an open inguinal hernia repair procedure on (b)(6) 2017 and the mesh was implanted. During the procedure, a doctor inserted the plug, cut a slit for the spermatic cord and, while fixating the onlay patch, the mesh ripped through the sutures the doctor was placing. The mesh was removed from the patient and another like device was used to complete the procedure. There were no patient consequences reported. No further information is available.
 
Manufacturer Narrative
The cause of described event could not be verified at the actual sample. The 2 detected custs present mostly cut appearance, only few single filaments were observed with rather broken appearance. No suture used for mesh fixation was present.
 
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Brand NameULTRAPRO COMFORT PLUG PRODUCT
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 Key6277283
MDR Text Key65729834
Report Number2210968-2017-60033
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K070224
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/12/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/25/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2018
Device Catalogue NumberUPLUG551
Device Lot NumberKD8GMRP0
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/16/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/16/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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