BEUDAMED
    FDA Adverse Event Other Summary report: N

    SAFESKIN LATEX GLOVE

    MDR report key: 14039 · Received June 15, 1994

    Report

    Report Number
    MW1002485
    Event Type
    Other
    Date Received
    June 15, 1994
    Date of Event
    May 24, 1994
    Report Date
    June 3, 1994
    Manufacturer
    SIME HEALTH LTD.
    Product Code
    LYY
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SD, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    PT DEVELOPED A RASH AROUND LIPS (EXTERNAL) AND EARS AFTER A 30-45 MINUTE DENTAL PROCEDURE FOR APPLICATION OF ORTHODONTIC APPLIANCES. CLINICAL APPEARANCE AND IMPRESSION WAS OF LATEX GLOVE HYPERSENSITIVITY. (SAME RPTR REFERRED TO IN 1002484.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAFESKIN LATEX GLOVE LATEX GLOVE LYY SIME HEALTH LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Other