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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PROCEED*SURG MESH/MULTI LYR MESH, SURGICAL, POLYMERIC

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ETHICON INC. PROCEED*SURG MESH/MULTI LYR MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number PCDN1
Device Problem Malposition of Device (2616)
Patient Problems Unspecified Infection (1930); Nausea (1970); Pain (1994); Not Applicable (3189)
Event Date 03/20/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). The review of the batch manufacturing records was conducted and the batch met all finished goods release criteria. To date the device has not been returned. If the device or further details are received at the later date a supplemental medwatch will be sent. This medwatch report is in response to receipt of maude event report mw5076154. Attempts are being made to obtain the additional information. To date no response has been provided. If further details are received at the later date a supplemental medwatch will be sent.
 
Event Description
It was reported that the patient underwent a hernia repair procedure on (b)(6) 2014 and the mesh was implanted to fix hernia. It was also reported that the mesh caused opening of stomach wall and leaking infection/staph infection inside stomach. The mesh was then removed on (b)(6) 2016 due to stated complications. This surgery has left lasting issues with the stomach and has affected the patient's ability to eat and keep food down due to nausea and pain. Additional information has been requested.
 
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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 30531
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key7654973
MDR Text Key112906648
Report Number2210968-2018-73983
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K060713
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation
Type of Report Initial
Report Date 06/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/31/2016
Device Catalogue NumberPCDN1
Device Lot NumberHDG078
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/05/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/16/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/02/2018 Patient Sequence Number: 1
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