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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 PCDR1
Device Problem Hole In Material (1293)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/10/2017
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.
 
Event Description
It was reported that the patient underwent an umbilical hernia procedure on (b)(6) 2017 and the mesh was implanted. During the procedure, the mesh was torn from the middle. There were no adverse patient consequences reported. Additional information has been requested.
 
Manufacturer Narrative
Additional information was requested and the following was received: was the outer case that the package arrived in damaged? - no. Was the seal of the package completely intact? - no. How was the procedure complete? - dr. Used proceed 4*6 mesh and in case i am present. Please confirm there was no patient consequence. - no. In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
 
Manufacturer Narrative
The actual sample was not damaged during shipment. The tear in the returned mesh device is most likely related to contact with a surgical instrument with sharp tip. The orc layer was most likely torn in its mid-section while grabbed and manipulated by the surgical devices such as hemostat or forceps with serrated tips. Based on examination of sample for the reported ¿tear¿ into mesh, existence of a potential cause related to manufacturing of device can be disregarded.
 
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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
darlene kyle
route 22 west po box 151
somerville, NJ 08876
9082182792
MDR Report Key6449618
MDR Text Key71470788
Report Number2210968-2017-31446
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K060713
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 03/10/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/31/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2018
Device Catalogue NumberPCDR1
Device Lot NumberKLG274
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/04/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/10/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/18/2016
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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