BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACURETTE CURETTE

    MDR report key: 687608 · Received February 8, 2006

    Report

    Report Number
    687608
    Event Type
    Malfunction
    Date Received
    February 8, 2006
    Date of Event
    February 1, 2006
    Report Date
    February 8, 2006
    Manufacturer
    ACMI CORPORATION
    Product Code
    HHK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US

    Narratives

    Description of Event or Problem · 1

    PATIENT IN THE OPERATING ROOM FOR SUCTION DILATATION AND CURETTAGE OF AN INCOMPLETE MISCARRIAGE, 6-7 WEEKS GESTATION. DURING SURGERY, IT WAS NOTED THAT THE PLASTIC SUCTION TIP (VACURETTE CURETTE)HAD A JAGGED EDGE. THE MISSING TIP WAS NOT FOUND UPON SEARCH OF THE ROOM. THE DOCTOR PERFORMED A HYSTEROSCOPY TO DETERMINE IF IT WAS WITHIN THE CAVITY AND WAS NEGATIVE. THE ULTRASOUND DONE IN RECOVERY ROOM WAS ALSO NEGATIVE. THE LOCATION OF THE TIP IS NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VACURETTE CURETTE CANNULA, VACUUM ASPIRATION HHK ACMI CORPORATION * VC00858

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR