BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TUTOMESH BOVINE PERICARDIUM

    MDR report key: 6998872 · Received November 3, 2017

    Report

    Report Number
    3002924436-2017-00017
    Event Type
    Injury
    Date Received
    November 3, 2017
    Report Date
    November 3, 2017
    Manufacturer
    TUTOGEN MEDICAL GMBH
    Product Code
    FTM
    UDI-DI
    04041543302967
    PMA / PMN Number
    K081538
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    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 (SIZE 4CM X 5CM) AND DEVELOPED A FISTULA POST-OPERATIVELY AT AN UNKNOWN DATE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. TO DATE, RTI/TMI HAS NOT RECEIVED ANY ADDTIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780826 TUTOMESH BOVINE PERICARDIUM SURGICAL MESH FTM TUTOGEN MEDICAL GMBH NOT PROVIDED 04041543302967

    Patients

    Seq Age Sex Outcome Treatment
    1 Other