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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PROCEED VENTRAL PATCH MESH, SURGICAL, POLYMERIC

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ETHICON INC. 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 Date 08/31/2017
Event Type  malfunction  
Manufacturer Narrative
One opened foil and an actual mesh sample of product code pvps, lot # la8jkbb0 in partial blood-soaked condition were received for analysis. 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 of performance - straps tear off device, could not be determined.
 
Manufacturer Narrative
The review of the batch manufacturing records was conducted and the batch met all finished goods release criteria. The product upon which this medwatch is based has been received, however, the evaluation is not yet complete. Any further information derived from the evaluation will be submitted in a supplemental 3500a form.
 
Event Description
It was reported that the patient underwent an umbilical hernia repair procedure on (b)(6) 2017 date and the mesh was implanted. During the procedure, the straps ripped while suturing. Another like device was used to complete the procedure. No further information is available.
 
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Brand NamePROCEED VENTRAL PATCH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville 08876 0151
Manufacturer (Section G)
ETHICON INC.-GMBH
robert-koch strasse 1
norderstedt
GM
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville 08876-0151
9082182792
MDR Report Key6900589
MDR Text Key106452938
Report Number2210968-2017-70373
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 09/01/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/28/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2018
Device Catalogue NumberPVPS
Device Lot NumberLA8JKBB0
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/20/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/25/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2017
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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