BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW

    MDR report key: 13869694 · Received March 23, 2022

    Report

    Report Number
    3003898228-2022-00002
    Event Type
    Malfunction
    Date Received
    March 23, 2022
    Date of Event
    February 14, 2022
    Report Date
    March 22, 2022
    Manufacturer
    FH INDUSTRIE
    Product Code
    KWT
    UDI-DI
    03661489651410
    PMA / PMN Number
    K112193
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    UNCOUPLING OF THE TWO HUMERAL PROSTHETIC PARTS, AT A DISTANCE OF 2 AND A HALF MONTHS AFTER FITTING. CLINICAL CONSEQUENCE: HOSPITALIZATION AND SURGICAL REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1089029 ARROW ARROW METALBACK HUM. INSERT D36 H00 KWT FH INDUSTRIE 265141 M02011 03661489651410

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown