BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFT TOUCH

    MDR report key: 41822 · Received September 17, 1996

    Report

    Report Number
    41822
    Event Type
    Injury
    Date Received
    September 17, 1996
    Date of Event
    March 17, 1996
    Report Date
    September 15, 1996
    Manufacturer
    EXECUTONE
    Product Code
    ILQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    RESIDENT WAS FOUND WITH A 5CM X 9CM DISCOLORED AREA ON L CHEEK WITH 2 SMALL BLACKENED CIRCLES IN UPPER PORTION. AREA WAS IN SHAPE OF CALL LIGHT WHICH WAS WITHOUT THE PROTECTIVE PLASTIC COVER BUT DID HAVE A LIGHT, CLEAR PLASTIC OVER. PLASTIC NOTED TO HAVE CONDENSATION AT TIME RESIDENT FOUND. UNABLE TO DETERMINE HOW ACTUALLY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFT TOUCH CALL LIGHT ILQ EXECUTONE UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention