BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACMI

    MDR report key: 512919 · Received February 6, 2004

    Report

    Report Number
    MW1031136
    Event Type
    Malfunction
    Date Received
    February 6, 2004
    Date of Event
    December 2, 2003
    Report Date
    February 6, 2004
    Manufacturer
    ACMI CORP
    Product Code
    FZS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS HAVING D&C PROCEDURE. WITH ROTATION OF THE SUCTION CURETTE, THE CATHETER TIP BROKE OFF INSIDE PT CAUSING UTERINE PERFORATION. PIECE WAS RETRIEVED. PT DID NOT REQUIRE FOLLOW UP PROCEDURE TO REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACMI VACURETTE CURETTE FZS ACMI CORP VACURETTE CURETTE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other