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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. GYNECARE MESH UNKNOWN MESH, SURGICAL

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ETHICON INC. GYNECARE MESH UNKNOWN MESH, SURGICAL Back to Search Results
Catalog Number MESHUNK
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Swelling (2091); Not Applicable (3189)
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 the 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. How are you currently feeling? if in your possession, may we have a copy of your initial 2010 operative report and operational report of scheduled no (b)(6) 2019 mesh removal procedure after completion? does ethicon have your permission to contact your surgeon, who performed initial procedure and/or will perform (b)(6) 2019 surgery, 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 attached. Please note: initially, in 2011-2013 the event regarding post-op outcome such as pain and swelling after 2010 inguinal hernia repair surgery was presented via mw5019193; at that time, the complaint did not meet reportability criteria since no medical/surgical intervention was provided.
 
Event Description
It was reported that the patient underwent an inguinal hernia repair in (b)(6) 2010 and the mesh was implanted. The patient experienced pain since the surgery. At this time, swelling and severe pain in the site of hernia repair. The pain has gotten progressively worse and affecting ability to work and perform regular chores. The revision surgery is scheduled for (b)(6) 2019 to remove the mesh. Additional information has been requested.
 
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Brand NameGYNECARE MESH UNKNOWN
Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
Manufacturer (Section G)
ETHICON INC.
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key8483677
MDR Text Key140934497
Report Number2210968-2019-80018
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/04/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberMESHUNK
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 Received09/05/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 04/04/2019 Patient Sequence Number: 1
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