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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PROLENE MESH 6X11CM MESH, SURGICAL, POLYMERIC

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ETHICON INC. PROLENE MESH 6X11CM MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number XCPMS3
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Pain (1994); Ambulation Difficulties (2544)
Event Type  Injury  
Manufacturer Narrative

(b)(4). The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot. 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. Attempts are being made to obtain the following information. To date no response has been provided. If further details are received at a 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?.

 
Event Description

It was reported by the patient that they underwent an inguinal hernia repair on (b)(6) 2013 and mesh was implanted. Following the procedure, the patient experienced great pain, infections and limited ability to walk. Additional information has been requested.

 
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Brand NamePROLENE MESH 6X11CM
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.-SAN LORENZO PR
road 183, km. 8.3
san lorenzo 00754
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key8344244
MDR Text Key136291409
Report Number2210968-2019-78912
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,FOREIGN,OTHER
Reporter Occupation
Type of Report Initial
Report Date 01/22/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/15/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/31/2017
Device Catalogue NumberXCPMS3
Device LOT NumberEPB148
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/22/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/03/2012
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: 02/15/2019 Patient Sequence Number: 1
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