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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 Migration (4003)
Patient Problems Erosion (1750); Incontinence (1928); Unspecified Infection (1930); Pain (1994); Abnormal Vaginal Discharge (2123); Discomfort (2330); Not Applicable (3189)
Event Date 06/29/2007
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.
 
Event Description
It was reported that the patient underwent a surgical procedure/ sacrocolpoplexy on (b)(6) 2007 and the mesh was implanted for vaginal prolapse. The patient started to experience vaginal discharge, continual infection and severe discomfort. It was also reported that the patient could feel sharp prongs protruding through the vaginal wall. This condition worsened until the partial removal of the protruding mesh. From that point the condition got worse with increasingly heavier discharge, infection, incontinence and sharp abdominal pain. More of the mesh was protruding through the vaginal wall. Additional information has been requested. After second opinion and ultrasound which confirmed, the mesh had eroded and formed a mass which was causing the pain, discharge and infection. The patient required the mesh to be removed immediately. It was also reported that the date of explantation was (b)(6) 2018. No further information is available.
 
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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 Key8263168
MDR Text Key133706458
Report Number2210968-2019-78493
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 consumer,foreign
Type of Report Initial
Report Date 01/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/20/2019
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/02/2019
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: 01/20/2019 Patient Sequence Number: 1
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