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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 Problems Hernia (2240); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
(b)(4). 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 laparoscopic ventral hernia repair procedure and mesh was implanted. The patient reported that the mesh ripped and failed. The mesh was removed in 2006 and new mesh was implanted. No additional information was provided.
 
Manufacturer Narrative
Date sent to fda: 11/29/2016. 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 Key6058245
MDR Text Key58422060
Report Number2210968-2016-14524
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 consumer
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/05/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/26/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberPCDN1
Device Lot NumberXEG033
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/29/2016
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

Patient Treatment Data
Date Received: 10/26/2016 Patient Sequence Number: 1
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