BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DORO QR3 SKULL CLAMP

    MDR report key: 11054508 · Received December 22, 2020

    Report

    Report Number
    3003923584-2020-00030
    Event Type
    Malfunction
    Date Received
    December 22, 2020
    Report Date
    December 2, 2020
    Manufacturer
    PRO MED INSTRUMENTS GMBH
    Product Code
    HBL
    UDI-DI
    04250435506196
    PMA / PMN Number
    K001808
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE NOT RECEIVED THE PRODUCT SO FAR AND THE CUSTOMER HAS NOT SENT US ANY FURTHER INFORMATION YET. DUE TO THE INITIAL CUSTOMER FEEDBACK WE DECIDED TO REPORT THIS CASE. 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

    OUR DISTRIBUTOR INFORMED US ON (B)(6) THAT ONE OF OUR PRODUCTS WAS INVOLVED IN AN INCIDENT. ACCORDING TO THE CUSTOMER, THE PATIENT'S HEAD FELL OUT OF THE CLAMP. THE PATIENT WAS NOT INJURED IN THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1524277 DORO QR3 SKULL CLAMP DORO® QR3 SKULL CLAMP HBL PRO MED INSTRUMENTS GMBH 1001.001 04250435506196

    Patients

    Seq Age Sex Outcome Treatment
    1 Other