BEUDAMED
    FDA Adverse Event Other Summary report: N

    CODMAN DOSPOSABLE PERFORATOR

    MDR report key: 65347 · Received December 23, 1996

    Report

    Report Number
    65347
    Event Type
    Other
    Date Received
    December 23, 1996
    Date of Event
    July 29, 1996
    Report Date
    October 2, 1996
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    HBF
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DISPOSABLE PERFORATOR, (14MM) FAILED TO STOP WHEN BONE (SKULL) PERFORATED THEREBY PERFORATING DURA AND THE BRAIN. NO ADVERSE AFFECTS FOR PT PER MD. QUESTIONABLE OPERATOR ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CODMAN DOSPOSABLE PERFORATOR 14MM HBF CODMAN & SHURTLEFF, INC. 14MM SINGLE USE BN804

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other