BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLUMBRA CLOTHING MEDICAL DEVICE

    MDR report key: 467745 · Received June 18, 2003

    Report

    Report Number
    MW1028776
    Event Type
    Injury
    Date Received
    June 18, 2003
    Date of Event
    May 31, 2003
    Report Date
    June 18, 2003
    Manufacturer
    SUN PRECAUTIONS
    Product Code
    MIW
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ANAPHYLAXIS. REGARDING SPECIALIZED CLOTHING MADE BY THE COMPANY: SUN PRECAUTIONS. THEIR CLOTHING LINE IS CALLED SOLUMBRA. THEY CLAIM THE CLOTHING IS A MEDICAL DEVICE" DESIGNED TO PROTECT THE WEARER FROM THE SUN. REPORTER WAS TOLD THE CLOTHING WAS SAFE, AND THAT NOTHING ABOUT IT SHOULD BE A HEALTH CONCERN. REPORTER WAS ENCOURAGED TO ORDER IT AND TRY IT. REPORTER ASKED IF IT WOULD BE OK IF THEY WASHED IT PRIOR TO TRYING IT ON. THEY AGREED THAT WAS OK. THEY WASHED THE ITEMS AS THEY NORMALLY WASH CLOTHING WITH THE SAME DETERGENT ETC. UPON TRYING THE CLOTHING ON, IN THE HOUSE, A SHIRT, PANT AND HAT, WITHIN MINUTES OF PUTTING THE FINAL GARMENT ON REPORTER BROKE OUT INTO A RASH, HIVES, ITCHY ALL OVER WHERE THE CLOTHING TOUCHED. THEIR SKIN BEGAN TO SWELL UP, THEIR TONGUE ALSO. REPORTER GOT DIZZY AND STARTED TO HAVE A HARD TIME BREATHING. EMERGENCY ANTIHISTAMINES WERE ADMINISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLUMBRA CLOTHING MEDICAL DEVICE SUN PROTECTIVE CLOTHING MIW SUN PRECAUTIONS SOLUMBRA CLOTHING MEDICAL DEVICE *
    2 SOLUMBRA CLOTHING MEDICAL DEVICE SUN PROTECTIVE CLOTHING MIW SUN PRECAUTIONS SOLUMBRA CLOTHING MEDICAL DEVICE *

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Life Threatening| R