BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTUBATION TUBING

    MDR report key: 6050289 · Received October 19, 2016

    Report

    Report Number
    MW5065547
    Event Type
    Injury
    Date Received
    October 19, 2016
    Report Date
    October 19, 2016
    Manufacturer
    UNK
    Product Code
    BTR
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAVE BEEN DIAGNOSED WITH A SEVERE ALLERGY TO POLYETHYLENE GLYCOL. THIS SUBSTANCE IS USED IN COUNTLESS PRODUCTS, MAKING ITS AVOIDANCE EXTREMELY DIFFICULT. I HAVE EXPERIENCED SEVERAL EPISODES OF ANAPHYLACTIC SHOCK REQUIRING EMERGENCY ROOM CARE DUE TO EXPOSURE. AS IT IS, MY BELIEF, CONSIDERED A HARMLESS INACTIVE INGREDIENT, IT FALLS OUTSIDE THE SCOPE OF MANDATED LABELING. THE SUBSTANCE IS CERTAINLY NOT HARMLESS TO ME. WHAT IS REQUIRED TO MOVE THIS SUBSTANCE FROM CLASSIFICATION OF A HARMLESS INACTIVE INGREDIENT TO ONE REQUIRING ITS INCLUSION ON PRODUCT INGREDIENT LABELS? THIS SUBSTANCE IN FOODS, MEDICINE, MEDICAL DEVICES, LUBRICANTS, COSMETICS, CAPE CIGARETTES, GEL STRIPS ON DISPOSABLE RAZORS, TOOTHPASTE, SHAMPOOS, COLONOSCOPY PREPARATIONS, ETC. MANUFACTURER/COMPOUNDER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692705 INTUBATION TUBING INTUBATION TUBING BTR UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| S