BEUDAMED
    FDA Adverse Event Other Summary report: N

    B-SPEED-REDUCER/77

    MDR report key: 348723 · Received August 17, 2001

    Report

    Report Number
    1045834-2001-00008
    Event Type
    Other
    Date Received
    August 17, 2001
    Date of Event
    July 24, 2001
    Report Date
    August 13, 2001
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    HBF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PERFORATOR ATTACHED TO ANSPACH SPEED REDUCER PUNCTURED INNER TABLE OF SKULL. THE PERFORATOR DID NOT STOP INSTEAD IT PLUNGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37937 B-SPEED-REDUCER/77 PERFORATOR DRIVER HBF THE ANSPACH EFFORT, INC. * 51156665

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention