BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2900753 · Received December 31, 2012

    Report

    Report Number
    2900753
    Event Type
    Malfunction
    Date Received
    December 31, 2012
    Date of Event
    December 28, 2012
    Report Date
    December 31, 2012
    Manufacturer
    BUSSE HOSPITAL DISPOSABLES
    Product Code
    HGH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS IN THE OPERATING SUITE. THE UTERUS WAS SOUNDED AND THEN SUCTION CURETTE PLACED TO THE FUNDUS AND THEN ATTACHED TO SUCTION. THE TUBING ITSELF WAS COLLAPSING AND THEREFORE TECHNIQUE WAS CHANGED TO SHARP CURETTAGE. SHARP CURETTAGE WAS DONE TO VERIFY UTERUS WAS EMPTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * CANNULA, SUCTION, UTERINE HGH BUSSE HOSPITAL DISPOSABLES * 66667-2

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR