BEUDAMED
    FDA Adverse Event Other Summary report: N

    SCHEIN STERILE LUBRICATING JELLY 4 OZ. TUBE

    MDR report key: 1819564 · Received August 25, 2010

    Report

    Report Number
    2128643-2010-00001
    Event Type
    Other
    Date Received
    August 25, 2010
    Date of Event
    February 9, 2010
    Report Date
    August 25, 2010
    Manufacturer
    TRIAD GROUP, INC.
    Product Code
    FHX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN USING SCHEIN STERILE LUBRICATING JELLY, 4 OZ. TUBE, LOT 9B121, OVER 30 PTS COMPLAINED OF VAGINAL IRRITATION. ALL PTS WERE PRESCRIBED A MEDICATED OINTMENT. UPON USING THE PRESCRIBED MEDICATED OINTMENT, THE SYMPTOMS HAVE RESOLVED.

    Description of Event or Problem · 1

    WHEN USING SCHEIN STERILE LUBRICATING JELLY, 4 OZ. TUBE, LOT 9B121, OVER 30 PTS COMPLAINED OF VAGINAL IRRITATION. ALL PTS WERE PRESCRIBED A MEDICATED OINTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCHEIN STERILE LUBRICATING JELLY 4 OZ. TUBE LUBRICATING JELLY FHX TRIAD GROUP, INC. 9B121

    Patients

    Seq Age Sex Outcome Treatment
    1