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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 Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative
Appropriate term / code not available (e2402) utilized to capture injury (e20).To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.
 
Event Description
It was reported by an attorney that the patient underwent pelvic surgery on an unk date and mesh was implanted.It was reported that the patient experienced an unknown event.No additional information was provided.
 
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Brand Name
GYNECARE MESH UNKNOWN
Type of Device
MESH, SURGICAL
Manufacturer (Section D)
ETHICON INC.
1000 route 202
raritan NJ 08869
Manufacturer (Section G)
ETHICON INC.-SOMERVILLE
p.o. box 151, route 22 west
somerville NJ 08876
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
MDR Report Key12316847
MDR Text Key266387972
Report Number2210968-2021-07327
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeSF
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Reporter Occupation Other
Type of Report Initial
Report Date 08/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received08/02/2021
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? No
Type of Device Usage Initial
Patient Sequence Number1
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