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U.S. Department of Health and Human Services

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

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JOHNSON & JOHNSON INTERNATIONAL ULTRAPRO PLUG MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number UPPM2
Device Problem Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/30/2017
Event Type  malfunction  
Manufacturer Narrative
We received for evaluation an opened ultrapro plug of the product code uppm2 (an onlay patch, a rim/body and an anchor). During visual inspection of the open sample it was observed body fluids on the implant mesh and the anchor and body was not connected; since the anchor was pull out of the body. In addition, the rim of the implant mesh present damaged. The onlay patch no present damaged or body fluids. It was observed that during our investigation the components present initial disintegration on the absorbable part of the mesh. It could not be determined what may have caused the reported incident.
 
Manufacturer Narrative
(b)(4). Date sent to the fda: 06/20/2017. The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot. Attempts are being 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 laparoscopic inguinal hernia repair on (b)(6) 2017 and mesh was used. During the procedure, the plug anchor ripped away from the rim prior to fixation. Another like device was used to complete the procedure. There were no adverse patient consequences reported. No additional information was provided.
 
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Brand NameULTRAPRO PLUG
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
darlene kyle
route 22 west po box 151
somerville, NJ 08876
9082182792
MDR Report Key6653886
MDR Text Key104752386
Report Number2210968-2017-60288
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/02/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/20/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2018
Device Catalogue NumberUPPM2
Device Lot NumberKL8CMHC0
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/06/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/12/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2016
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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