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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PROCEED* MULTI-LAYER LAMINATE MESH MESH, SURGICAL, POLYMERIC

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ETHICON INC. PROCEED* MULTI-LAYER LAMINATE MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number PCDN1
Device Problem Hole In Material (1293)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/15/2016
Event Type  No Answer Provided  
Manufacturer Narrative
(b)(4). Date sent to the fda: 12/16/2016. 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 a hernia repair procedure on (b)(6) 2016 and the mesh was implanted. During the procedure, the mesh tore. Another like device was used to complete a procedure. There were no patient consequences reported. No further information is available.
 
Manufacturer Narrative
The evaluation indicated the tears in the mesh device is not related to performance of the mesh, rather it is believed to be a result of tack placement technique used during this surgical procedure.
 
Manufacturer Narrative
In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
 
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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.-CORNELIA
655 ethicon circle
cornelia GA 30531
Manufacturer Contact
krystina laguna
route 22 westp o box 151
somerville, NJ 08876
9082183043
MDR Report Key6181302
MDR Text Key62628543
Report Number2210968-2016-15545
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K060713
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/29/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/16/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberPCDN1
Device Lot NumberJLG194
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/11/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/31/2017
Was Device Evaluated by Manufacturer? No
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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