BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAFESKIN LIGHTLY POWDERED EXAM

    MDR report key: 201533 · Received December 11, 1998

    Report

    Report Number
    2084395-1998-00048
    Event Type
    Injury
    Date Received
    December 11, 1998
    Date of Event
    March 3, 1998
    Report Date
    December 11, 1998
    Manufacturer
    SAFESKIN CORP.
    Product Code
    LYY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    DENTAL ASSISTANT

    Narratives

    Description of Event or Problem · 1

    ON NOVEMBER 13, 1998, SAFESKIN CORPORATION RECEIVED A COPY OF A VOLUNTARY MEDWATCH REPORT (REPORT NO. 1013627) WITH THE FOLLOWING EVENT DESCRIPTION: "MY HANDS & FACE SWELL & TURN RED. I GET A LARGE LUMP IN MY THROAT, MY EYES GET WATERY AND ITCHY. MY NOSE PLUGS UP, I GET ASTHMA & HIVES IN MY MOUTH. I DID GET THIS TYPE OF REACTION WHEN I WORKED WITH LATEX GLOVES & GO INTO A DENTAL OFFICE OR A HOSPITAL. IT RUINED MY CAREER AS A DENTAL ASSISTANT! I LOVED MY JOB VERY MUCH. I WAS NEVER TOLD ABOUT LATEX ALLERGIES. NOW I CAN'T EVEN GO OUT TO EAT WITHOUT ASKING IF THEY USE LATEX GLOVES TO PREPARE FOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAFESKIN LIGHTLY POWDERED EXAM LATEX POWDERED EXAM GLOVE LYY SAFESKIN CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other