BEUDAMED
    FDA Adverse Event Other Summary report: N

    GOWN, LARGE, POLY-REINFORCED

    MDR report key: 475914 · Received August 5, 2003

    Report

    Report Number
    1423507-2003-00095
    Event Type
    Other
    Date Received
    August 5, 2003
    Date of Event
    July 4, 2003
    Report Date
    August 5, 2003
    Manufacturer
    CARDINAL HEALTH
    Product Code
    FYA
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER INDICATES THE GOWN IS CAUSING AN ALLERGIC REACTION TO THE STAFF THAT USES IT, SPECIFICALLY IN THE ELBOWS AND WRIST. STAFF MEMBER'S ALLERGIES HAVE GOTTEN WORSE WHEN USING THIS GOWN. CUSTOMER HAS BEEN USING A TOPICAL CREAM GIVEN BY THEIR DR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GOWN, LARGE, POLY-REINFORCED GOWN, LARGE, POLY-REINFORC FYA CARDINAL HEALTH 9010 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other