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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PROCEED VENTRAL PATCH::SIZE 6.4 X 6.4 CM MESH, SURGICAL, POLYMERIC

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ETHICON INC. PROCEED VENTRAL PATCH::SIZE 6.4 X 6.4 CM MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number XCPVPM
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fatigue (1849); Pain (1994)
Event Date 01/01/2010
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. If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
Event Description
It was reported that a patient underwent an unknown procedure on an unknown date in 2020. It was reported that the patient had a proceed hernia mesh installed and for the past 4 years suffered with debilitating, chronic abdominal pain and extreme fatigue. It was reported that the patient had been to 4 different doctors for evaluation. It was also reported that for the past 6 months, the patient had been in limbo; due partly to covid. It was reported that the surgeon the patient spoke with last ordered a ct scan and after reviewing the results, expressed a concern for having to dig out the existing mesh. It was also reported that he suggested the patient hold off until it becomes life-threatening. It was reported that the patient has to deal with this pain every day. It was reported that the patient's exercise is severely limited because so many exercise motions cause more pain and discomfort.
 
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Brand NamePROCEED VENTRAL PATCH::SIZE 6.4 X 6.4 CM
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876
Manufacturer (Section G)
ETHICON INC.-GMBH
robert-koch strasse 1
norderstedt GA
GM
Manufacturer Contact
elba bello
p.o. box 151, route 22 west
somerville, NJ 08876
9082183429
MDR Report Key10156188
MDR Text Key196203972
Report Number2210968-2020-04582
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K061533
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/15/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/22/2011
Device Catalogue NumberXCPVPM
Device Lot NumberCB8LBSZ0
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 Received07/07/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/22/2010
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: 06/15/2020 Patient Sequence Number: 1
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