BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACURETTE CANNULA, BERKELEY CURVED 9 MM

    MDR report key: 595617 · Received July 9, 2004

    Report

    Report Number
    2124979-2004-00012
    Event Type
    Malfunction
    Date Received
    July 9, 2004
    Date of Event
    December 2, 2003
    Report Date
    July 8, 2004
    Manufacturer
    ACMI CORPORATION
    Product Code
    HHK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS HAVING A D&C PROCEDURE. WITH ROTATION OF THE SUCTION CURETTE, THE CATHETER TIP BROKE OFF INSIDE PT. CAUSING UTERINE PERFORATION. PT. NOT REQUIRE FOLLOW UP PROCEDURE TO REPAIR. THERE IS NO INJURY OR ADVERSE EFFECT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VACURETTE CANNULA, BERKELEY CURVED 9 MM CURETTE HHK ACMI CORPORATION 21552 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN