BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTELON TISSUE REINFORCEMENT

    MDR report key: 4925796 · Received July 16, 2015

    Report

    Report Number
    3010673515-2015-00003
    Event Type
    Injury
    Date Received
    July 16, 2015
    Date of Event
    June 16, 2015
    Report Date
    July 16, 2015
    Manufacturer
    INTERNATIONAL LIFE SCIENCES, D/B/A ARTELON
    Product Code
    FTL
    PMA / PMN Number
    K071887
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT EXPLANTED. SURGEON PROVIDED COMMUNICATION THAT APPARENT INFECTION HAS CLEARED. DEVICE HISTORY RECORDS FOR BOTH LOTS WERE REVIEWED AND ALL ACCEPTANCE CRITERIA WERE MET.

    Description of Event or Problem · 1

    DEVICE NOT EXPLANTED. SURGEON THINKS APPARENT INFECTION HAS CLEARED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463776 ARTELON TISSUE REINFORCEMENT TISSUE REINFORCEMENT FTL INTERNATIONAL LIFE SCIENCES, D/B/A ARTELON 31048 1304003997

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention