BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLUMBRA

    MDR report key: 281757 · Received June 10, 2000

    Report

    Report Number
    MW1019111
    Event Type
    Injury
    Date Received
    June 10, 2000
    Date of Event
    May 22, 2000
    Report Date
    June 10, 2000
    Manufacturer
    WETMORE ASSOC, INC.
    Product Code
    MIW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RPTR HAD ORDERED SOME CLOTHING (257.75 WORTH). RPTR TOLD THEM THAT THEY WERE VERY ALLERGIC TO THE SUN AND UV LIGHTS AND THAT RPTR HAS LUPUS. RPTR TALKED WITH A SALESMAN ON THE PHONE, WHO SAID THAT THE SAGE GREEN COLOR WOULD WORK WELL FOR THEM. THEY DID NOT WORK AT ALL. RPTR HAD THE WORST LUPUS FLARE THEY HAVE EVER HAD AFTER BEING EXPOSED TO THE SUN ONLY 30 MINS. 75% OF RPTR'S BACK WAS COVERING IN PURPLE/BLACK LESIONS. RPTR WAS VERY SICK. THIS CO CLAIMS THEIR CLOTHES PROVIDE PROTECTION FROM THE SUN AND UV LIGHT. BUT RPTR FOUND THEY PROVIDE LESS PROTECTION THAN A REGULAR LONG SLEEVE COTTON SHIRT. RPTR WROTE A LETTER TO THEM AND SUGGESTED THEY SHOULD NOT OFFER THOSE CLOTHES TO PEOPLE THAT ARE ALLERGIC TO THE SUN OR THAT HAVE LUPUS. RPTR TOLD THEM THAT THE CLOTHES DID NOT WORK AT ALL. THEY HAVE NOT RESPONDED TO RPTR'S LETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLUMBRA SUN PROTECTIVE CLOTHING MIW WETMORE ASSOC, INC. #1970 #4950 #2925 #3930 *

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Life Threatening