BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK RX

    MDR report key: 496776 · Received November 3, 2003

    Report

    Report Number
    MW1030183
    Event Type
    Malfunction
    Date Received
    November 3, 2003
    Date of Event
    October 1, 2003
    Report Date
    November 3, 2003
    Manufacturer
    QUICK RX
    Product Code
    KSD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    HEAT SEALER USED TO PACKAGE COMPOUNDED UNIT DOSE RESPIRATORY MEDS (ALBUTEROL-IPRATROPIUM BUDESONIDE ETC.) MALFUNCTIONED CAUSING VIALS TO OPEN AND CONTENTS LEAK OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICK RX HEAT SEALER KSD QUICK RX * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other