BEUDAMED
    FDA Adverse Event Other Summary report: N

    GOWN AURORA NONREINFORCED XLA

    MDR report key: 620627 · Received July 11, 2005

    Report

    Report Number
    1423395-2005-00011
    Event Type
    Other
    Date Received
    July 11, 2005
    Date of Event
    June 5, 2005
    Report Date
    July 8, 2005
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    FYA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY THE NURSE BROKE OUT IN A RASH IN THE WRIST AREA AFTER WEARING THE GOWN. THIS WAS NOT THE FIRST TIME THE GOWN WAS USED. NURSE REQUIRED MEDICAL TREATMENT (OINTMENT, MISSED WORK). NURSE HAS CHANGED TO AN ALTERNATE GOWN WITH NO FURTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GOWN AURORA NONREINFORCED XLA SURGICAL GOWN FYA MEDLINE INDUSTRIES, INC. DYNJP2702 4117602

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other