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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 05/23/2017
Event Type  malfunction  
Manufacturer Narrative
Received one opened foil and an actual mesh sample in partial blood-soaked condition. During visual inspection of the used sample, body fluids on the implant and partial detachment of the wing from load ring was observed at the device. In addition, the welding of the load ring was damaged in a corner. The partial separation of the wings at the welding area of the load ring may occur during handling. Therefore, the pds components are broken into fragments and a blue suture is visible which fixated the wing with the bottom mesh. As the pvp product is absorbable and was returned opened, during our investigation the sample started to separate into their components, due to degradation process of the mesh has already begun. According to the sample condition, the assignable cause could not be determined.
 
Manufacturer Narrative
(b)(4). 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. Attempts are being made to obtain the following information. To date no response has been provided. If further details are received at a later date a supplemental medwatch will be sent. Additional information indicates ¿the problem (which i have circled in the picture)¿. Is this a picture of the actual device used in the procedure? if yes, please forward the ¿picture¿ / photograph. The lot number kj8pdpb0 is not valid. Please clarify the lot number involved.
 
Event Description
It was reported that the patient underwent an unknown procedure on (b)(6) 2017 and mesh was used. During the procedure, the tab let go of the net and was hanging only in a small piece in the middle. The issue was discovered when the net was in place and the surgeon pulled up the flaps and then noticed that one looked damaged. Another like device was used to complete the procedure. There were no adverse patient consequences reported. Additional information has been requested.
 
Manufacturer Narrative
The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot. Additional information was requested and the following was obtained: we do not have the box, but i can see that it is possible that the lot number can be: kj8dpdb0 photo was provided for evaluation. Upon visual inspection of the picture, it was noted that straps folded in were damaged and sample has body fluids. However, no conclusion could be reached as how the sample was damaged due to not returned for analysis. During insertion, be certain to avoid kinking the patch (e. G. , by using clamp or extensive folding/rolling etc. ). Once the mesh patch has been inserted through the defect, manipulate the strap carefully to facilitate proper positioning of the patch. Pulling carefully on the suture loops allows the mesh patch to flatten itself against the abdominal wall.
 
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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 Key6646624
MDR Text Key105341999
Report Number2210968-2017-60276
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeSW
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,Followup
Report Date 05/29/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/16/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2018
Device Catalogue NumberPVPM
Device Lot NumberKJ8DPDB0
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/11/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/11/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2016
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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