BEUDAMED
    FDA Adverse Event Summary report: N

    MEDICATION CUP

    MDR report key: 19947 · Received February 23, 1995

    Report

    Report Number
    MW1005206
    Date Received
    February 23, 1995
    Date of Event
    November 25, 1994
    Report Date
    February 17, 1995
    Manufacturer
    SOLO CUP CO.
    Product Code
    KYW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT HAD BEEN ADMITTED TO THE HOSP WITH GI BLEEDING. WHILE A PROCEDURE WAS BEING DONE, THE PLASTIC BOTTOM OF A MEDICATION CUP WAS FOUND IN THE PT'S ESOPHAGUS. THE REPORTER STATED THAT THE PIECE OF PLASTIC IS IN A PERFECT CIRCLE AND IS IMPRINTED WITH CO'S NAME. THE REPORTER ALSO STATED THAT SHE USED SHARP SCISSORS AND A PILL CRUSHER AND WAS UNABLE TO CUT THE BOTTOM OFF IN A PERFECT CIRCLE. THE CUP, THE REPORTER ASSUMES THE BOTTOM CAME FROM, IS A SEAMLESS CUP. THE PT IS DEVELOPMENTALLY DISABLED AND THEREFORE IS NOT ABLE TO TELL HOW THIS MAY HAVE HAPPENED. THE REPORTER STATED THAT ONE WEEK BEFORE THE PLASTIC WAS FOUND, THE PT HAD A CHOKING EPISODE DOCUMENTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDICATION CUP MEDICATION CUP KYW SOLO CUP CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR