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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HERNIA MESH

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HERNIA MESH Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Unspecified Infection (1930); Liver Damage/Dysfunction (1954)
Event Date 02/01/2016
Event Type  Death  
Event Description
(b)(6) died on (b)(6) 2016 due to drug induced liver injury due to taking levofloxacin and rifampin for a hernia mesh infection. The mesh could not be removed because of the liver damaged, and a liver transplant could not be done because of the infection. So will something be done about this? dates of use: (b)(6) 2016. Diagnosis or reason for use: hernia mesh infection. Event abated after use stopped or dose reduced? no.
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Type of DeviceHERNIA MESH
MDR Report Key5662263
MDR Text Key45486923
Report NumberMW5062351
Device Sequence Number1
Product Code FTM
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 05/10/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/10/2016
Is this an Adverse Event Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 05/10/2016 Patient Sequence Number: 1