BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIGHT RELIEF

    MDR report key: 6085455 · Received November 5, 2016

    Report

    Report Number
    MW5065873
    Event Type
    Death
    Date Received
    November 5, 2016
    Date of Event
    August 14, 2016
    Report Date
    November 5, 2016
    Manufacturer
    LIGHTRELIEF, LLC
    Product Code
    ILY
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    SUDDEN DEATH. TOOK BUMEX FOR 8 DAYS AS PRESCRIBED, HE WAS A BORDER LINE DIABETIC MALE AND (B)(6). THE MEDICATION HAS NO WARNING ON IT FOR SUDDEN DEATH, BUT REVIEWS SHOW IT CAUSES SUDDEN DEATH. HE WAS IN PERFECT ATHLETIC CONDITION PRIOR TO BURNING FOOT WITH A LIGHT DEVICE CALLED "LIGHT RELIEF". IT IS INFRARED LIGHT. WHILE HE WAS USING THE DEVICE, IT 3RD DEGREE BURNED HIS FOOT AND TOE, WHICH CAUSED IN INFECTION AND RETENTION OF WATER IN HIS BODY AND DEATH. HE BURNED HIS FOOT WITH THE LIGHT ON (B)(6) AND DIED ON (B)(6) 2016. DOSE OR AMOUNT: 1 TABLET, FREQUENCY: EVERY 12 HRS, ROUTE: TAKEN BY MOUTH, APPLIED TO A SURFACE, USUALLY THE SKIN. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: NO. DATES OF USE: (B)(6) 2016. DIAGNOSIS OR REASON FOR USE: THE BUMEX TO REMOVE RETAINED WATER AFTER BURN, PAIN IN FOOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731971 LIGHT RELIEF LIGHT RELIEF ILY LIGHTRELIEF, LLC LR150 LR150

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death ASPIRIN| BUMEX 1MG | HUMALOG| ONE A DAY VITAMIN