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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 Material Protrusion/Extrusion (2979)
Patient Problem Erosion (1750)
Event Date 06/19/2018
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. Attempts are being made to obtain the additional information. To date no response has been provided. If further details are received at the later date a supplemental medwatch will be sent. The patient demographic info: age, weight, bmi at the time of index procedure? the initial approach for the index surgical procedure? the diagnosis and indication for the initial surgical procedure? were there any intra-operative complications? other relevant patient history/concomitant medications? product code and lot #? describe any medical/surgical intervention for exposure including dates and surgical findings. 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 the patient underwent a sacrocolpopexy on (b)(6) 2017 and the unknown mesh was implanted. At (b)(6) 2018 follow-up, a good result for prolapse management was presented but small area of mesh exposed vaginally 2bc-t3-s2, causing some soreness. The patient prescribed a vaginal estrogen treatment, then will need reassessment and partial mesh removal if needed. Additional information has been requested.
 
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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 Key7742857
MDR Text Key115815074
Report Number2210968-2018-74836
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 company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 07/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/02/2018
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?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/12/2018
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: 08/02/2018 Patient Sequence Number: 1
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