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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); Pain (1994); 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 the later date a supplemental medwatch will be sent. Additional information was requested, and the following was obtained: the surgeon has informed that she doesn't have the additional information, no further information available. The patient demographic info: age, weight, bmi at the time of index procedure? name and indication of initial surgical procedure in 2014 when mesh was implanted? other relevant patient history/concomitant medications? any concurrent procedure / device implantation? were there any intra-operative complications? when was the vaginal mesh erosion first noted by a physician? mesh erosion into vagina diagnostic confirmation? was any deficiency or anomaly of the mesh? if yes, please describe it. Onset date of pain from the initial surgery? was the chronic pain resolved after mesh removal? please provide a date and details / surgical findings of mesh removal? what is physician¿s opinion as to the etiology of or contributing factors to this event what is the patient's current status? mesh product code and lot number implanted in 2014? if applicable, will product be returned, return date, tracking information?.
 
Event Description
It was reported that the patient underwent an unknown gynecological surgery in 2014 and the unknown mesh was implanted. The patient experienced mesh erosion into the vagina and chronic pain. The patient underwent a mesh removal, complex and difficult surgery. 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
Manufacturer (Section G)
ETHICON INC.
Manufacturer Contact
kara ditty-bovard
p.o. box 151, route 22 west
somerville, NJ 08876
6107428552
MDR Report Key9392921
MDR Text Key168608674
Report Number2210968-2019-90366
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,o
Reporter Occupation
Type of Report Initial
Report Date 11/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/02/2019
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
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/12/2019
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: 12/02/2019 Patient Sequence Number: 1
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