BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULATED DEVICE BIT

    MDR report key: 19169 · Received January 26, 1995

    Report

    Report Number
    MW1004877
    Event Type
    Malfunction
    Date Received
    January 26, 1995
    Date of Event
    January 6, 1995
    Report Date
    January 10, 1995
    Manufacturer
    ACUMED, INC.
    Product Code
    HTT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AN INSTRUMENTATION DEVICE TIP BROKE OFF IN PT'S SURGERY SITE. PHYSICIAN WAS ABLE TO RETRIEVE PIECE. NO INJURY TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CANNULATED DEVICE BIT HTT ACUMED, INC. D/N AT7032

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other