BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAGE TOOTHETTE ORAL CARE

    MDR report key: 1346801 · Received March 16, 2009

    Report

    Report Number
    1346801
    Event Type
    Injury
    Date Received
    March 16, 2009
    Date of Event
    March 3, 2009
    Report Date
    March 3, 2009
    Manufacturer
    SAGE PRODUCTS, INC
    Product Code
    EFW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NURSE REPORTED THAT SHE ADMINISTERED SAGE ORAL CARE AT 13:00. SUBSEQUENT TO THAT SHE NOTED CHEMICAL IRRITATION TO SKIN ON RIGHT WRIST AND THUMB. SHE STATED SHE BACKTRACKED AND DISCOVERED IT WAS FROM ORAL CARE SOLUTION. SHE ASSESSED PATIENT AND NOTED PATIENT'S TONGUE AND LIPS WERE WHITE FROM REACTION TO TREATMENT. PATIENT DENIED ANY PAIN AND PACKAGE WAS RETRIEVED FROM TRASH. SKIN CONDITIONS OF BOTH PATIENT AND STAFF NURSE RESOLVED TO NORMAL BY THE NEXT DAY. NO HARM TO EITHER INDIVIDUAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAGE TOOTHETTE ORAL CARE ORAL CARE PRODUCT EFW SAGE PRODUCTS, INC 13835/1

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR