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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Incontinence (1928)
Event Date 01/01/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). 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. The patient demographic info: age, weight, bmi at the time of index procedure, name of initial surgical procedure? the diagnosis and indication for the initial surgical procedure? what were current symptoms following the index surgical procedure? onset date? what are the patient comorbidities/ concomitant medications? product code(s) and lot #¿s were any concomitant procedures performed? onset date/time of the pain from surgery? location and character of the pain? what medical intervention was given for the pain management? results? has incontinence changed from pre-surgery condition? is incontinence worse, better, or returned to the same? please provide surgical findings of the reoperations. Does the surgeon believe that the ethicon product (tvt) involved caused and/or contributed to the hernia? what is physician¿s opinion as to the etiology of or contributing factors to these events? what is the patient's current status? event related to tvt device on (b)(6) 2000 reported via mw # 2210968-2021-03618, event related to tvt device on (b)(6) 2001 reported via mw # 2210968-2021-03619.
 
Event Description
It was reported that a patient underwent a sling procedure on (b)(6) 2002 and the mesh was implanted. It was reported that the patient had stress incontinence. It was also reported that the patient had a right inguinal hernia in 2008. It was reported that the patient removed a portion of the mesh in (b)(6) 2017. Additional information was requested.
 
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Brand NameGYNECARE MESH UNKNOWN
Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
ETHICON INC.
1000 route 202
raritan NJ 08869
Manufacturer (Section G)
ETHICON INC.
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
MDR Report Key11705008
MDR Text Key261316623
Report Number2210968-2021-03620
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeEI
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Reporter Occupation
Type of Report Initial
Report Date 03/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/23/2021
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: 04/22/2021 Patient Sequence Number: 1
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