BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DORO QR3 SKULL CLAMP TEFLON

    MDR report key: 11911533 · Received June 1, 2021

    Report

    Report Number
    3003923584-2021-00015
    Event Type
    Injury
    Date Received
    June 1, 2021
    Date of Event
    May 6, 2021
    Report Date
    May 6, 2021
    Manufacturer
    PRO MED INSTRUMENTS GMBH
    Product Code
    HBL
    UDI-DI
    04250435500781
    PMA / PMN Number
    K001808
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE DEVICE HAD A MINOR DEVIATION ON 1 OF 4 MEASURING POINTS, IT GENERALLY CANNOT BE EXCLUDED THAT THE DEVICE HAS CONTRIBUTED TO THE EVENT. HOWEVER GIVEN THE MINOR DEGREE OF THE DEVIATION WE SUSPECT THAT THE DEVICE DID NOT CONTRIBUTE TO THE EVENT. WE SUSPECT, THAT MAYBE THE PINNING TECHNIQUE HAS BEEN NOT OPTIMAL AS DESCRIBED IN THE INSTRUCTION MANUAL: "ADJUST THE SKULL CLAMP TO THE WIDTH OF THE PATIENT'S HEAD IN THE MANNER THAT THE TWO SKULL PINS IN THE ROCKER ARM ARE EQUIDISTANT FROM THE CENTERLINE OF THE HEAD AND THE SINGLE SKULL PIN AT THE EXTENSION ASSEMBLY IS IN LINE WITH THIS CENTERLINE."

    Description of Event or Problem · 1

    DISTRIBUTOR INFORMED OUR SERVICE DEPARTMENT ON THE 6TH OF MAY THAT ONE OF OUR PRODUCTS WAS INVOLVED IN A SLIPPAGE THAT RESULTED IN A LACERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812728 DORO QR3 SKULL CLAMP TEFLON DORO® QR3 SKULL CLAMP TEFLON HBL PRO MED INSTRUMENTS GMBH 3003-009 04250435500781

    Patients

    Seq Age Sex Outcome Treatment
    1 Other