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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 PCDH1
Device Problem Migration (4003)
Patient Problems Adhesion(s) (1695); Erosion (1750); Fever (1858); Inflammation (1932); Nausea (1970); Pain (1994); Sepsis (2067); Not Applicable (3189); No Code Available (3191)
Event Date 01/23/2017
Event Type  Injury  
Manufacturer Narrative

(b)(4). 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. 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. If in your possession, may we have a copy of your operative report? does ethicon have your permission to contact your surgeon, in the event ethicon would like to contact your surgeon for more clinical information to be used for a product quality complaint investigation? if so, please provide your surgeon¿s name, contact information and sign release of medical information form.

 
Event Description

It was reported that the patient underwent a hernia repair procedure on (b)(6) 2006 and the mesh was implanted. The patient experienced problems with the mesh, pains in terms of could not walk. On (b)(6) 2017 the patient had an emergency surgery to remove the mesh. The patient was running a high fever, was starting to feel sick and had pains in her legs. A ct scan revealed the mesh had eroded around her diaphragm, small intestine, large intestine as well as a colon. The surgeon opined the patient had sepsis built up inside her as well has having bile spread through her body like cancer. Once the mesh was removed, and the patient was sutured up without a mesh. Another mesh was not put in immediately. The surgeon opined that the patient's body needed time to heal. The patient was given a colostomy bag. A few months later when she was healed up, the colostomy bag was reversed on (b)(6) 2017. During that same surgery the patient had another brand mesh implanted. On (b)(6) 2017 the patient became sick again and the surgeon found that she had a leak in her sphincter one of her pipe lines, her vein area was leaking, they had to have a surgery, so they could sew it up so that it would not leak into the stomach area. After the first surgery, the patient was in rehab, and the she came home for a week, to get clearance, and then she went back to rehab and stayed until (b)(6) 2017. 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 GA 30531
Manufacturer Contact
kara ditty-bovard
p.o. box 151, route 22 west
somerville, NJ 08876-0151
6107428552
MDR Report Key8372777
MDR Text Key137247962
Report Number2210968-2019-79097
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK060713
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/30/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/27/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/30/2006
Device Catalogue NumberPCDH1
Device LOT NumberXGG104
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/29/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/22/2006
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: 02/27/2019 Patient Sequence Number: 1
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