BEUDAMED
    FDA Adverse Event Death Summary report: N

    TUTOMESH BOVINE PERICARDIUM

    MDR report key: 6789100 · Received August 11, 2017

    Report

    Report Number
    3002924436-2017-00011
    Event Type
    Death
    Date Received
    August 11, 2017
    Report Date
    September 28, 2017
    Manufacturer
    TUTOGEN MEDICAL GMBH
    Product Code
    FTM
    PMA / PMN Number
    K081538
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHODS: RTI/TMI WILL CONDUCT A RE-REVIEW OF THE PRODUCT HISTORY FOR TUTOMESH BOVINE PERICARDIUM, PACKAGING PRODUCTION RECORDS, ENVIRONMENTAL MONITORING AND DISTRIBUTION INFORMATION FOR RELATED COMPLAINTS ASSOCIATED WITH THE LOT, ONCE UNIQUE IDENTIFIERS ARE PROVIDED.

    Additional Manufacturer Narrative · 1

    PRODUCT IDENTIFIERS WERE NOT PROVIDED. THEREFORE, A COMPREHENSIVE RE-REVIEW OF RECORDS COULD NOT BE CONDUCTED. DEGRADATION OF THE PRODUCT WITHIN THIS SHORT PERIOD OF TIME (2 DAYS), COULD ONLY BE CAUSED BY A MASSIVE INFLAMMATORY RESPONSE, WHICH IS EITHER TRIGGERED BY A MASSIVE INFECTION OR THE RESULT OF AN ALLERGIC REACTION TO THE BOVINE PRODUCT.

    Description of Event or Problem · 1

    RTI SURGICAL, INC (RTI) AND TUTOGEN MEDICAL (B)(4) (TMI), A WHOLLY OWNED SUBSIDIARY OF RTI, RECEIVED A COMPLAINT ON (B)(6) 2017 WHICH INDICATED THAT A PATIENT WAS IMPLANTED WITH A TUTOMESH IMPLANT AS AN ABDOMINAL CLOSER AFTER BOWEL PERFORATION. TWO DAYS LATER, THE SURGEON FOUND OUT THAT THE MESH WAS PARTIALLY DISINTEGRATED. FIVE DAYS AFTER IMPLANTATION, THE PATIENT DIED OF SEPTIC SHOCK. ADDITIONAL INFORMATION HAS BEEN REQUESTED. TO DATE, RTI HAS NOT RECEIVED ANY ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS PROVIDED ON 09/22/2017. THE PATIENT HAD NOT BEEN TESTED FOR ALLERGY ASSOCIATED WITH BOVINE PRODUCTS. THEREFORE, IT IS UNKNOWN IF THE PATIENT WAS ALLERGIC TO BOVINE PRODUCTS. THE ABDOMINAL WOUND WAS COVERED WITH JELONET SHEET ONE LAYER (UNKNOWN IF AFTER IMPLANTATION OF THE TUTOMESH OR AFTER REMOVAL). BLOOD TESTS FOR INFLAMMATION MARKERS AND MICROBIOLOGICAL ANALYSIS WERE PERFORMED. RESULTS WERE NOT PROVIDED FOR REVIEW. AFTER REMOVAL OF THE TUTOMESH AT AN UNKNOWN DATE, A DYNAMESH (MANUFACTURER UNKNOWN) WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569453 TUTOMESH BOVINE PERICARDIUM SURGICAL MESH FTM TUTOGEN MEDICAL GMBH NOT PROVIDED TO DATE

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O