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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 01/20/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). 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. Additional information was requested and the following was obtained: what was the name of the procedure? umbilical hernia repairs. How was the procedure completed? with another ventral patch. It was reported that ¿quantity x 2- pug in /removed tabs/ would not stick- ¿, please be specific. Did the ¿straps¿ not attach to the tissue?. The tabs broke off as the mesh was being moved in to position before any fixation of the mesh had begun. Did the ¿suture loops¿ not attach? was there any issues with the suture? what suture?.
 
Event Description
It was reported that the patient underwent an umbilical hernia repair procedure on (b)(6) 2017 and the mesh was implanted. During the procedure, tabs of the device broke off as the mesh was being moved in to position before any fixation of the mesh had begun. Another mesh was used to complete the procedure. There were no adverse consequences reported.
 
Manufacturer Narrative
The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.
 
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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
darlene kyle
route 22 west po box 151
somerville, NJ 08876
9082182792
MDR Report Key6311954
MDR Text Key66866014
Report Number2210968-2017-60051
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K061533
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/25/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/08/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2018
Device Catalogue NumberPVPM
Device Lot NumberKE8CSZB0
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/28/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/01/2016
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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