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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 Migration or Expulsion of Device (1395)
Patient Problems Erosion (1750); Burning Sensation (2146); Not Applicable (3189)
Event Type  Injury  
Manufacturer Narrative
(b)(4). 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.
 
Event Description
It was reported that the patient underwent a gynecological procedure on an unknown date and mesh was implanted. Two years following the procedure, the patient presented with burning in the vagina. A few strands of exposed mesh were found in the right paraurethral sulcus and trimmed in clinic. Additional information will be requested.
 
Manufacturer Narrative
Additional information was requested and the following was received: the initial approach for the index surgical procedure? - 2016 the patient demographic info: age, weight, bmi at the time of index procedure - na any concurrent procedure/device implantation? - na were there any intra-operative complications? - na when was the mesh exposure first noted by a physician? -(b)(6) 2018 mesh exposure site/location, symptoms and diagnostic confirmation? - right paraurethral sulcus. Describe medical/surgical intervention for exposure including dates and findings - (b)(6) 2018 trimmed tape in clinic product code and lot # - na what is physician¿s opinion as to the etiology of or contributing factors to this event - na did the patient's condition improve after the device was completely removed? - na.
 
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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.
p.o. box 151, route 22 west
somerville 08876 0151
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key7337535
MDR Text Key102330586
Report Number2210968-2018-71427
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/14/2018
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/14/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/14/2018 Patient Sequence Number: 1
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