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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOHNSON & JOHNSON INTERNATIONAL PROCEED VENTRAL PATCH MESH, SURGICAL, POLYMERIC

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JOHNSON & JOHNSON INTERNATIONAL PROCEED VENTRAL PATCH MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number PVPS
Device Problem Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Date sent to the fda: 01/24/2017. 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 umbilical hernia repair procedure on unknown date and the mesh was implanted. During the procedure, when the doctor started to suture the implanted mesh, the tab pulled off of the mesh product. The mesh was removed and another like device was used to complete the procedure. There were no patient consequences reported. No further information is available.
 
Manufacturer Narrative
In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria. The cause of the strap breakage could not be clarified. The partial separation of the wings at the welding with the load ring may occur during handling and does not have any effect on the product properties and functionality. It should be noted that before pvp placement enough space should be prepared to ensure proper unfolding of the device. Once the mesh patch has been inserted into the defect, manipulate the suture loops to facilitate proper positioning of the patch.
 
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Brand NamePROCEED VENTRAL PATCH
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 Key6274745
MDR Text Key65673040
Report Number2210968-2017-60032
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K061533
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 Received01/24/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2017
Device Catalogue NumberPVPS
Device Lot NumberJM8DZPB0
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 Manufactured11/01/2015
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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