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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 PVPM
Device Problem Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/12/2016
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 umbilical hernia repair procedure on (b)(6) 2016 and the mesh was implanted. During placing a device, tabs tore off. Another like mesh was used to complete the procedure. No further information is available.
 
Manufacturer Narrative
The actual mesh shows that one strap was completely broken off at the load ring and the other one shows cut off appearance. The cause of the described event could not be determined based on the condition of the actual implant (folded and disintegrated). The appearance of disintegration is expected after the long exposure period (about 12 weeks) to air and humidity.
 
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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
kenneth clark
route 22 westp o box 151
somerville, NJ 08876
9082183547
MDR Report Key5987274
MDR Text Key55936083
Report Number2210968-2016-60030
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/12/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/29/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2018
Device Catalogue NumberPVPM
Device Lot NumberKD8CGZB0
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/10/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/10/2017
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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