BEUDAMED
    FDA Adverse Event Other Summary report: N

    WOLFF SYSTEM DIAMOND SUN S

    MDR report key: 43382 · Received September 19, 1996

    Report

    Report Number
    1054665-1996-00019
    Event Type
    Other
    Date Received
    September 19, 1996
    Date of Event
    September 6, 1996
    Report Date
    September 18, 1996
    Manufacturer
    OSRAM SYLVANIA, INC.
    Product Code
    LEJ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER WITH AVERAGE SKIN COLOR CAME TO TAN FOR 20 MINS. CALLED 3 DAYS LATER TO REPORT SHE HAD SUFFERED 2ND TO 3RD DEGREE BURNS. SHE REPORTED THAT 3 HRS AFTER SHE HAD TANNED SHE WAS SHOWING A LITTLE COLOR. 2 DAYS AFTER TANNING WENT TO THE EMERGENCY ROOM SUFFERING OR CLAIMING SHE HAD RECEIVED 2ND AND 3RD DEGREE BURNS. SHE ALSO SAID THAT SHE RECEIVED THE BURNS EVERYWHERE ON HER BODY EXCEPT FOR HER LEGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WOLFF SYSTEM DIAMOND SUN S LOW PRESSURE FLOURESCENT ULTRAVIOLET LAMP LEJ OSRAM SYLVANIA, INC. DSS-71-100W *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other