BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROMAX SYSTEM CUTTERS

    MDR report key: 1193165 · Received October 6, 2008

    Report

    Report Number
    1045834-2008-00105
    Event Type
    Malfunction
    Date Received
    October 6, 2008
    Date of Event
    December 4, 2007
    Report Date
    October 6, 2008
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    ERL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SURGEON STATED THE CUTTER TIP DISINTEGRATED DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROMAX SYSTEM CUTTERS CUTTERS ERL THE ANSPACH EFFORT, INC. S-3B 336131

    Patients

    Seq Age Sex Outcome Treatment
    1 NA