BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SALIVART ORAL MOISTURIZER

    MDR report key: 854439 · Received May 22, 2007

    Report

    Report Number
    1519179-2007-00002
    Event Type
    Injury
    Date Received
    May 22, 2007
    Date of Event
    March 12, 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
    IL, 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 HOSPITAL COULD NOT DETERMINE THE CAUSE OF THE PT'S ILLNESS. ADDITIONALLY, THE PT HAD THREE CANS OF SALIVART AFFECTED BY THE RECALL (1 CAN OF LOT 06AA001 AND 2 CANS OF LOT 06AA006) THAT SHE USED FOR 5 TO 6 MONTHS PRIOR TO BECOMING ILL. THE PT HAD BEEN USING ONE OF THE CANS REPEATEDLY FOR SEVERAL WEEKS PRIOR TO BECOMING ILL. THEREFORE, SINCE THESE THREE CANS HAD BEEN USED WITHOUT INCIDENT BY THE PT PRIOR TO BECOMING ILL, THESE THREE CANS MAY NOT HAVE CONTAINED ANY OF THE LOW LEVELS OF CONTAMINATION FOUND BY GEBAUER DURING TESTING. BASED ON THE INCONCLUSIVE FINDINGS INTO THE CAUSE OF THE ADVERSE EVENT, WE CAN NOT VERIFY THAT THE ILLNESSES DESCRIBED IN THE COMPLAINTS WERE NOT ATTRIBUTABLE TO SALIVART.

    Description of Event or Problem · 1

    THE PT HAD BEEN USING SALIVART ORAL MOISTURIZER (1 CAN OF LOT 06AA001 AND 2 CANS OF LOT 06AA006) FOR 5 TO 6 MONTHS PRIOR TO BECOMING ILL. THE PT BEGAN EXPERIENCING NAUSEA, VOMITING AND DIARRHEA AND WAS HOSPITALIZED FOR 7 WEEKS DUE TO DEHYDRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SALIVART ORAL MOISTURIZER SALIVART LFD GEBAUER CO. 0386-009-75 06AA001

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization