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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 Erosion (1750); Pain (1994)
Event Type  Injury  
Manufacturer Narrative
(b)(4). Attempts were 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 date and name of initial surgical procedure? the diagnosis and indication for the initial surgical procedure? the initial approach for the index surgical procedure? what are the patient comorbidities/concomitant medications? were any concomitant procedures performed? were there any intra-operative complications? onset date/time of the pain from surgery? was medical intervention given for the pain management? results? when was the mesh exposure first noted by a physician? please provide date and surgical findings of the re-operation. Product code and lot # what is physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status?.
 
Event Description
It was reported that a patient underwent a gynecological procedure on an unknown date and the mesh was implanted. It was reported that the patient experienced vaginal exposure, bilat groin pain, and pelvic pain. It was also reported that the patient had a complete removal. 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 Key12678544
MDR Text Key277908342
Report Number2210968-2021-10161
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 foreign,other
Reporter Occupation
Type of Report Initial
Report Date 09/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/22/2021
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 Received09/24/2021
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: 10/22/2021 Patient Sequence Number: 1
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