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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 03/16/2016
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. Actual sample was received with both straps separated from the device body. However, user handling was determined to be the cause of the issue. The device and loose straps presented used, blood contaminated condition. The suture loops were intact and did not appear to have been utilized.
 
Event Description
It was reported that a patient underwent a ventral hernia repair on (b)(6) 2016 and mesh was used. When trying to implant the mesh, the straps were separated from the rings on the mesh. Another like device was used to complete the procedure. There were no adverse consequences for the patient.
 
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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 NJ 08876 0151
Manufacturer (Section G)
ETHICON INC.-GMBH
robert-koch strasse 1
norderstedt D-228 51
GM D-22851
Manufacturer Contact
guillermo villa
route 22 west po box 151
somerville, NJ 08876
9082180707
MDR Report Key5540946
MDR Text Key41661431
Report Number2210968-2016-07711
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
Report Date 03/16/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/01/2016
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 NumberJM8CLMB0
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/31/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/16/2016
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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