BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DORO QR3 SKULL CLAMP

    MDR report key: 10492686 · Received September 4, 2020

    Report

    Report Number
    3003923584-2020-00023
    Event Type
    Malfunction
    Date Received
    September 4, 2020
    Date of Event
    July 22, 2020
    Report Date
    August 6, 2020
    Manufacturer
    PRO MED INSTRUMENTS GMBH
    Product Code
    HBL
    UDI-DI
    04250435506196
    PMA / PMN Number
    K001808
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS INSPECTED AND TESTED ON 10TH OF AUGUST 2020. WITHIN THIS INSPECTION, FUNCTIONAL TESTING AND VISUAL INSPECTION WAS MADE. THE RESULT WAS: THE USER HAS COMBINED THE PMI PRODUCT WITH A THIRD PARTY COMPONENT WHICH MAY HAVE CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    CUSTOMER INFORMED US ON 06.08.2020 ABOUT A SLIPPAGE WITH A SKULL CLAMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    956931 DORO QR3 SKULL CLAMP DORO® QR3 SKULL CLAMP HBL PRO MED INSTRUMENTS GMBH 1001.001 04250435506196

    Patients

    Seq Age Sex Outcome Treatment
    1