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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 (4003)
Patient Problems Erosion (1750); Calcium Deposits/Calcification (1758)
Event Date 01/01/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4). Attempts are being made to obtain the following information. To date no response has been provided. If further details are received at a later date a supplemental medwatch will be sent. The patient demographic info: age, weight, bmi at the time of index procedure, date and name of initial surgical procedure? the diagnosis and indication for the initial surgical procedure? what were current symptoms following the index surgical procedure? onset date? what are the patient comorbidities/ concomitant medications? the initial approach for the index surgical procedure? any concurrent procedure/ device implantation? were there any intra-operative complications? when was the mesh extrusion first noted by a physician? mesh extrusion symptoms and diagnostic confirmation? describe any medical/ surgical intervention for extrusion including dates and surgical findings. Product code and lot #? 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 a patient underwent a gynecological procedure on an unknown date in 2021 and the mesh was implanted. It was reported that the tape extruded into bladder with stone formation and bladder symptoms. Additional information was requested.
 
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Brand NameGYNECARE MESH UNKNOWN
Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
ETHICON INC.
1000 route 202
raritan NJ 08869
Manufacturer (Section G)
ETHICON INC.
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
MDR Report Key11705428
MDR Text Key247981435
Report Number2210968-2021-03629
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Reporter Occupation
Type of Report Initial
Report Date 03/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
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 Received03/23/2021
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: 04/22/2021 Patient Sequence Number: 1
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