BEUDAMED
    FDA Adverse Event Other Summary report: N

    DISPOSABLE SURGICAL GOWN

    MDR report key: 18878 · Received January 9, 1995

    Report

    Report Number
    MW1004701
    Event Type
    Other
    Date Received
    January 9, 1995
    Date of Event
    December 15, 1994
    Report Date
    December 28, 1994
    Manufacturer
    JOHNSON AND JOHNSON PRODUCTS
    Product Code
    FYA
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SUDDEN ONSET OF HIVES AND PROGRESSING DYSPNEA AFTER PUTTING ON SURGICAL GOWN. TREATED IN EMERGENCY ROOM WITH BENADRYL 25 AND PROVENTIL NEBULIZER, WITH RESOLUTION OF SYMPTOMS WITHIN ONE HOUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE SURGICAL GOWN DISPOSABLE SURGICAL GOWN FYA JOHNSON AND JOHNSON PRODUCTS S03183

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other