BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRANIAL PERFORATOR TIP

    MDR report key: 440034 · Received January 24, 2003

    Report

    Report Number
    MW1027359
    Event Type
    Malfunction
    Date Received
    January 24, 2003
    Date of Event
    December 4, 2002
    Report Date
    January 17, 2003
    Manufacturer
    ACRA-CUT INC.
    Product Code
    HBF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    14 MM CRANIAL PERFORATOR TIP DID NOT STOP AND DISENGAGE WHEN SUPPOSED TO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRANIAL PERFORATOR TIP CRANIAL PERFORATOR TIP HBF ACRA-CUT INC. 200-271 4490

    Patients

    Seq Age Sex Outcome Treatment
    1 NA