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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 Problems Calcium Deposits/Calcification (1758); Unspecified Infection (1930); Pain (1994)
Event Type  Injury  
Manufacturer Narrative
Product complaint #: (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. 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 a patient underwent a gynecological procedure for stress incontinence on an unknown date in 2002 and the mesh was implanted. It was reported that the patient experienced infections and pain after the implant and was taught to self catheterize. The mesh was removed on an unknown date in 2019. It was also reported that the patient is having kidney trouble with stones and infection. No device will be returned.
 
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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 Key12530347
MDR Text Key274589974
Report Number2210968-2021-08861
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation
Type of Report Initial
Report Date 08/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/24/2021
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 Received08/27/2021
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: 09/24/2021 Patient Sequence Number: 1
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