BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 503199 · Received December 17, 2003

    Report

    Report Number
    MW1030550
    Event Type
    Malfunction
    Date Received
    December 17, 2003
    Date of Event
    December 3, 2003
    Report Date
    December 17, 2003
    Manufacturer
    KERR
    Product Code
    KYX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    A FAMILY MEMBER BROUGHT BACK THIS 1602 BOTTLE WHICH WAS USED TO DISPENSE A PT'S MEDICINE WITH THE BOTTLE DISTORTED AND BROWN. ANOTHER BOTTLE OPENED ALSO HAD A SIMILAR DISTORTION. THE BROKEN PIECES COULD GET INTO THE SYRUP AND HARM THE PT. HOWEVER NO PT WAS HARMED IN THIS CASE. THE MANUFACTURER HAS BEEN CONTACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * OVAL PLASTIC CHILD RESISTANT BOTTLE KYX KERR * *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN