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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pain (1994)
Event Type  Injury  
Event Description
It was reported that a patient underwent an unknown procedure on an unknown date and the mesh was implanted. It was reported that the patient still suffers from it.
 
Manufacturer Narrative
Product complaint # (b)(4). (b)(4). If further details are received at a later date a supplemental medwatch will be sent.
 
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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 Key12914638
MDR Text Key286003785
Report Number2210968-2021-12261
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation
Type of Report Initial
Report Date 12/02/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Date Manufacturer Received11/03/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial

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