BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACURETTE

    MDR report key: 673723 · Received January 24, 2006

    Report

    Report Number
    673723
    Event Type
    Malfunction
    Date Received
    January 24, 2006
    Date of Event
    December 22, 2005
    Report Date
    January 24, 2006
    Manufacturer
    ACMI CORPORATION
    Product Code
    HHK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS DISPOSABLE DEVICE WAS PACKAGED AS AN 8MM CURVED VACURETTE. WHEN PACKAGE WAS OPENED AN 8MM STRAIGHT VACURETTE WAS INSIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VACURETTE VACUUM ASPIRATION CURETTE HHK ACMI CORPORATION * VC00829

    Patients

    Seq Age Sex Outcome Treatment
    1 *