BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DORO® QR3 SKULL CLAMP

    MDR report key: 14773774 · Received June 22, 2022

    Report

    Report Number
    3003923584-2022-00010
    Event Type
    Injury
    Date Received
    June 22, 2022
    Report Date
    May 23, 2022
    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
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER HAS NOT YET SENT THE PRODUCT IN FOR INVESTIGATION. WE WILL PERFORM A FOLLOW-UP AS SOON AS THE PRODUCT HAS ARRIVED AND THE FINDINGS HAVE BEEN COMPLETED.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER DOES NOT SEND THE PRODUCT TO THE MANUFACTURER FOR INSPECTION.

    Description of Event or Problem · 0

    CUSTOMER INFORMED OUR SERVICE DEPARTMENT ON THE 23RD OF MAY 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
    1895910 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