MAUDE Adverse Event Report: HERNIA MESH

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.

• Brand Name: HERNIA MESH
• Type of Device: HERNIA MESH
• MDR Report Key: 5662263
• MDR Text Key: 45486923
• Report Number: MW5062351
• Device Sequence Number: 1
• Product Code: FTM
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 05/10/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 67 YR
• Patient Weight: 136