BEUDAMED
    FDA Adverse Event Death Summary report: N

    FORMATION

    MDR report key: 232366 · Received July 14, 1999

    Report

    Report Number
    2431480-1999-00005
    Event Type
    Death
    Date Received
    July 14, 1999
    Report Date
    July 13, 1999
    Manufacturer
    HUDSON INDUSTRIES, INC.
    Product Code
    IKY
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CO'S CUSTOMER, E-MAILED HUDSON INDUSTRIES TO INFORM CO A PHYSICIAN CLAIMED TWO (2) PTS DIED AS A RESULT OF LAYING ON GEL OVERLAY. IT WAS REPORTED EACH PT DEVELOPED SEVERE SKIN RASHES AND DIED OF SEPSIS. NO FURTHER PT INFO WAS AVAILABLE. CO'S CUSTOMER, PHONED FDA FOR MEDWATCH WHICH INDICATED HUDSON INDUSTRIES SHOULD SUBMIT THIS AS AN MDR REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FORMATION GEL / FOAM MATTRESS OVERLAY IKY HUDSON INDUSTRIES, INC. FORM100 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death