BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DORO SKULL CLAMP RADIOLUCENT

    MDR report key: 11900738 · Received May 28, 2021

    Report

    Report Number
    3003923584-2021-00013
    Event Type
    Injury
    Date Received
    May 28, 2021
    Date of Event
    April 27, 2021
    Report Date
    April 30, 2021
    Manufacturer
    PRO MED INSTRUMENTS GMBH
    Product Code
    HBL
    UDI-DI
    04250435502181
    PMA / PMN Number
    K032331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT COULD NOT BE CLARIFIED WHETHER AN INJURY TO THE PATIENT HAD OCCURRED, BUT AS THERE WAS A POTENTIAL RISK REPORTED ("HEAD SLIPPED") WE DECIDED TO REPORT THIS CASE. 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 10 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 · 1

    CUSTOMER INFORMED OUR SERVICE DEPARTMENT ON THE 30TH OF APRIL THAT THE PATIENTS HEAD SLIPPED DURING A PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801329 DORO SKULL CLAMP RADIOLUCENT DORO® SKULL CLAMP RADIOLUCENT HBL PRO MED INSTRUMENTS GMBH 3034-00 04250435502181

    Patients

    Seq Age Sex Outcome Treatment
    1 Other