BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARAPOST

    MDR report key: 7996005 · Received October 23, 2018

    Report

    Report Number
    2416455-2018-00012
    Event Type
    Malfunction
    Date Received
    October 23, 2018
    Report Date
    October 23, 2018
    Manufacturer
    COLTENE WHALEDENT INC.
    Product Code
    ELR
    UDI-DI
    D661P68501
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ATTACHMENT: [DEVICE EVALUATION 2416455-2018-00012.XML].

    Description of Event or Problem · 1

    POST BROKE IN PATIENT'S MOUTH. DR IS LOOKING FOR EXPLANATION AS HE HAS NEVER HAD THIS HAPPEN BEFORE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838632 PARAPOST POST ELR COLTENE WHALEDENT INC. 19596 D661P68501

    Patients

    Seq Age Sex Outcome Treatment
    1