BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SALIVART ORAL MOISTURIZER

    MDR report key: 854438 · Received May 22, 2007

    Report

    Report Number
    1519179-2007-00001
    Event Type
    Injury
    Date Received
    May 22, 2007
    Date of Event
    March 14, 2007
    Report Date
    May 21, 2007
    Manufacturer
    GEBAUER CO.
    Product Code
    LFD
    PMA / PMN Number
    981693
    Removal / Correction Number
    1519179-2/2/07-001-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE AS TO WHETHER THE ADVERSE EVENT WAS CAUSED BY SALIVART OR IS ATTRIBUTABLE TO THE PTS UNDERLYING HEALTH ISSUES OR MEDICAL TREATMENTS. THE PT HAD BEEN USING AFFECTED UNITS OF SALIVART FOR A CONSIDERABLE PERIOD OF TIME PRIOR TO BECOMING ILL. THE PT WAS ALSO UNDERGOING CHEMOTHERAPY AND THE SYMPTOMS FOR CHEMOTHERAPY AND THE SYMPTOMS ASSOCIATED WITH USE OF CONTAMINATED SALIVART UNITS ARE ALMOST IDENTICAL MAKING IT DIFFICULT TO DETERMINE THE CAUSE OF THE ADVERSE EVENT. ONE OF THE ADVERSE EVENTS DESCRIBED IN THE COMPLAINT WAS ALSO WEIGHT LOSS. ADDITIONAL INVESTIGATION IDENTIFIED THAT THE PT, ALTHOUGH RECOVERED FROM ALL SYMPTOMS, CONTINUES TO LOSE WEIGHT, WHICH INDICATES THAT THIS PARTICULAR ADVERSE EVENT MAY NOT HAVE BEEN ATTRIBUTED TO SALIVART SINCE HE HAS NOT USED THE PRODUCT FOR A CONSIDERABLE PERIOD OF TIME. BASED ON THE INCONCLUSIVE FINDINGS INTO THE CAUSE OF THE ADVERSE EVENT, WE CAN NOT VERIFY THAT THE ILLNESS DESCRIBED IN THE COMPLAINT WAS NOT ATTRIBUTABLE TO SALIVART. ADD'L LOT# 06AA005.

    Description of Event or Problem · 1

    THE PT WAS USING SALIVART ORAL MOISTURIZER, WHICH IS CURRENTLY BEING RECALLED, OVER AN EXTENDED PERIOD OF TIME AND ON A FREQUENT BASIS. THE PT WAS UNDERGOING RADIATION THERAPY AND EXPERIENCE NAUSEA, VOMITING, STOMACH CRAMPS, AND WAS ADMITTED TO THE HOSPITAL FOR SEVEN WEEKS DUE TO DEHYDRATION. ATTRIBUTES WEIGHT LOSS SINCE SEPTEMBER 2006 TO USAGE OF SALIVART (140 LBS. TO 126 LBS.).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SALIVART ORAL MOISTURIZER SALIVART LFD GEBAUER CO. 0386-009-75 06AA004

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization RADIATION THERAPY