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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON ETHICON PHYSIOMESH

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ETHICON ETHICON PHYSIOMESH Back to Search Results
Lot Number JM8CHTD0
Device Problem Nonstandard Device (1420)
Patient Problem No Information (3190)
Event Date 04/12/2016
Event Type  Injury  
Event Description

Hernia mesh recall, patient requiring second surgery to repair due to recall. Dates of use: (b)(6) 2016 (b)(6) 2017. Diagnosis or reason for use: recall of hernia mesh.

 
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Brand NameETHICON PHYSIOMESH
Type of DeviceETHICON PHYSIOMESH
Manufacturer (Section D)
ETHICON
MDR Report Key6463383
MDR Text Key72135208
Report NumberMW5068937
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 04/04/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/04/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/01/2017
Device LOT NumberJM8CHTD0
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
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

Patient TREATMENT DATA
Date Received: 04/04/2017 Patient Sequence Number: 1
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