BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DORO® QR3 SKULL CLAMP

    MDR report key: 14186282 · Received April 22, 2022

    Report

    Report Number
    3003923584-2022-00004
    Event Type
    Injury
    Date Received
    April 22, 2022
    Date of Event
    March 18, 2022
    Report Date
    March 25, 2022
    Manufacturer
    PRO MED INSTRUMENTS GMBH
    Product Code
    HBL
    UDI-DI
    04250435506196
    PMA / PMN Number
    K001808
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 (2.36N BELOW TOLERANCE) OF THE DEVIATION IT IS VERY UNLIKELY THAT THE DEVICE HAS CONTRIBUTED 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 · 0

    CUSTOMER INFORMED OUR SERVICE DEPARTMENT ON THE (B)(6) THAT ONE OF OUR PRODUCTS WAS INVOLVED IN A CASE WHERE A LACERATION OCCURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1714564 DORO® QR3 SKULL CLAMP DORO® QR3 SKULL CLAMP HBL PRO MED INSTRUMENTS GMBH 1001.001 04250435506196

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other