BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DORO QR3 SKULL CLAMP

    MDR report key: 10552395 · Received September 18, 2020

    Report

    Report Number
    3003923584-2020-00025
    Event Type
    Malfunction
    Date Received
    September 18, 2020
    Date of Event
    August 18, 2020
    Report Date
    August 20, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT WAS INJURED IN THIS CASE, BUT DUE TO THE POTENTIAL RISK WE DECIDED TO REPORT THIS CASE. THE DEVICE WAS INSPECTED AND TESTED ON (B)(6). WITHIN THIS INSPECTION, FUNCTIONAL TESTING AND VISUAL INSPECTION WAS MADE. THE RESULT WAS: THE DEVICE SHOWED BEGINNING NORMAL WEAR AND TEAR. INTERVAL OF THE SUPPLIER MAINTENANCE WAS EXCEEDED BY THE CUSTOMER.

    Description of Event or Problem · 1

    CUSTOMER SERVICE WAS CONTACTED ON (B)(6) 2020 FROM CUSTOMER. CUSTOMER STATED A SLIPPAGE RELATING TO THE USE OF A SKULL CLAMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1021747 DORO QR3 SKULL CLAMP DORO® QR3 SKULL CLAMP HBL PRO MED INSTRUMENTS GMBH 1001.001 04250435506196

    Patients

    Seq Age Sex Outcome Treatment
    1