BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DORO® QR3 SKULL CLAMP TEFLON

    MDR report key: 14521289 · Received May 27, 2022

    Report

    Report Number
    3003923584-2022-00008
    Event Type
    Injury
    Date Received
    May 27, 2022
    Date of Event
    March 25, 2022
    Report Date
    May 10, 2022
    Manufacturer
    PRO MED INSTRUMENTS GMBH
    Product Code
    HBL
    UDI-DI
    04250435500781
    PMA / PMN Number
    K001808
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    AS THE DEVICE WAS OUT OF SPECIFICATION DUE TO WEAR AND TEAR, IT GENERALLY CANNOT BE EXCLUDED THAT THE DEVICE HAS CONTRIBUTED TO THE EVENT. THE INTERVAL OF THE SUPPLIER MAINTENANCE WAS EXCEEDED FOR MORE THAN 3 YEARS BY THE CUSTOMER. DUE TO THIS CIRCUMSTANCE, WE CANNOT EXCLUDE THAT THE DEVIATIONS FOUND ARE THE RESULT OF NORMAL WEAR AND TEAR AND COULD HAVE BEEN DETECTED DURING ANNUAL MAINTENANCE.

    Description of Event or Problem · 0

    CUSTOMER INFORMED OUR SERVICE DEPARTMENT ON THE 10TH 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
    1709654 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 Unknown Other