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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PROCEED VENTRAL PATCH 4.3 CM X 4.3 CMT MESH SURGICAL POLYMERIC

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ETHICON INC. PROCEED VENTRAL PATCH 4.3 CM X 4.3 CMT MESH SURGICAL POLYMERIC Back to Search Results
Lot Number LK8CHHB0
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/14/2019
Event Type  malfunction  
Event Description
During hernia surgery, mesh to be placed fell apart in places. All parts were able to be retrieved.
 
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Brand NamePROCEED VENTRAL PATCH 4.3 CM X 4.3 CMT
Type of DeviceMESH SURGICAL POLYMERIC
Manufacturer (Section D)
ETHICON INC.
MDR Report Key8560492
MDR Text Key143541310
Report NumberMW5086229
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/22/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/26/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2019
Device Lot NumberLK8CHHB0
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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