BEUDAMED
    FDA Adverse Event Other Summary report: N

    CMI

    MDR report key: 236064 · Received August 13, 1999

    Report

    Report Number
    MW1016969
    Event Type
    Other
    Date Received
    August 13, 1999
    Date of Event
    July 16, 1999
    Report Date
    July 26, 1999
    Manufacturer
    COLUMBIA MEDICAL, INC.
    Product Code
    HDB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO RECEIVED 10/07/99: AFTER AN INVESTIGATION, THE SUSPECT MEDICAL DEVICE WAS NOT MANUFACTURED BY UTAH MEDICAL PRODUCTS OR COLUMBIA MEDICAL. THE VACUUM AND VACUUM CUP IN QUESTION IS MADE BY PRISM ENTERPRISES, INC., MIGHTYVAC VACUUM AND VACUUM CUP PN#007M.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CMI VACUUM EXTRACTOR HDB COLUMBIA MEDICAL, INC. * *
    2 * HDB

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DAY Other MIGHTYVAC BY PRISM, MUSHROOM SHAPEDCUP REF. #007M