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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 or Expulsion of Device (1395)
Patient Problems Erosion (1750); Blood Loss (2597); 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 in 2013 and mesh was implanted.The patient also underwent a hysterectomy on an unknown date and for an unspecified reason.The patient experienced vaginal bleeding and posterior vaginal mesh extrusion.The patient is on a list for mesh excision.No additional information has been provided.
 
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Brand Name
GYNECARE MESH UNKNOWN
Type of Device
MESH, SURGICAL
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville 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 08876-0151
9082182792
MDR Report Key7071277
MDR Text Key93349693
Report Number2210968-2017-71508
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
Reporter Occupation Other
Type of Report Initial
Report Date 11/03/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberMESHUNK
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/03/2017
Initial Date FDA Received11/30/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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