BEUDAMED
    FDA Adverse Event Other Summary report: N

    WALGREEN'S 2TSP MEDICINE SPOON

    MDR report key: 2845048 · Received November 7, 2012

    Report

    Report Number
    2183416-2012-00001
    Event Type
    Other
    Date Received
    November 7, 2012
    Date of Event
    June 17, 2012
    Report Date
    November 6, 2012
    Manufacturer
    APOTHECARY PRODUCTS, INC.
    Product Code
    KYX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) WAS RECEIVED BY APOTHECARY PRODUCTS, INC. CUSTOMER SERVICE REP, FROM PT'S ATTORNEY ON (B)(6) 2012. ATTORNEY CLAIMED THAT PT ((B)(6)) WAS TAKING MEDICATION (AMOXICILLIN) PURCHASED AT (B)(6) WITH A 2 TSP MEDICINE SPOON DISPENSED BY (B)(6), IN A CLEAR WRAPPER, MANUFACTURED BY APOTHECARY PRODUCTS, INC. PT WAS REPORTED TO BEGIN CHOKING AND THROWING UP UPON TAKING THE MEDICATION, AND DID THROW-UP A PIECE OF PLASTIC PRESUMABLY FROM INSIDE THE MEDICINE SPOON. THE SIZE OF THE PLASTIC CANNOT BE DETERMINED AS THE DEVICE NOR THE PIECE OF PLASTIC HAVE NOT BEEN RETURNED TO THE MANUFACTURER FOR EVAL. THE 2 TSP MEDICINE SPOON (B)(4) FROM APOTHECARY PRODUCTS, INC. IS MANUFACTURED AND PACKAGED AT DEN HARTOG INDUSTRIES, IN (B)(4) (CONTACT MANUFACTURER). A SUPPLIER CORRECTIVE ACTION REQUEST ((B)(4)) WAS ISSUED TO DEN HARTOG BY APOTHECARY PRODUCTS, INC. DEN HARTOG INDUSTRIES CONDUCTED AN INVESTIGATION INCLUDING A 100% SORT OF PRODUCT. THE INVESTIGATION CONCLUDED THAT A PIECE OF PLASTIC COULD POSSIBLY HAVE BEEN EJECTED FROM A GRANULATOR BEHIND THE INJECTION MOLDING MACHINE. THE GRANULATOR HAS BEEN PHYSICALLY MOVED AND NEW LOADING PROCEDURE HAS BEEN IMPLEMENTED IN WHICH THE MEDICINE SPOON WILL BE HELD UPSIDE-DOWN PRIOR TO LOADING INTO THE PACKAGING MACHINE TO ENSURE FUTURE REMOVAL OF ANY POSSIBLE CONTAMINANTS DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    THE MINOR PT RECEIVED MEDICATION ALONG WITH A MEDICATION FROM (B)(6) AND BECAME SERIOUSLY ILL DUE TO A BROKEN PIECE OF PLASTIC FROM THE MEDICINE SPOON. THE PT (B)(6) WAS GIVEN AMOXICILLIN TO TREAT AN ILLNESS AND USED A 2TSP MEDICINE SPOON PROVIDED BY (B)(6), MANUFACTURED BY APOTHECARY PRODUCTS, INC. THE PT BEGAN CHOKING AND THROWING UP AND THREW-UP A PIECE OF PLASTIC THAT WAS ALLEGED TO HAVE BEEN INSIDE OF THE MEDICINE SPOON. AT THIS TIME THERE HAS BEEN NO EVIDENCE OF EMERGENCY MEDICAL TREATMENT, OR A MEDICAL REPORT FROM THE PT'S PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALGREEN'S 2TSP MEDICINE SPOON LIQUID MEDICATION DISPENSER KYX APOTHECARY PRODUCTS, INC. 67147WG UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Life Threatening