BEUDAMED
    FDA Adverse Event Other Summary report: N

    KOTEX SECURITY TAMPON (SUPER)

    MDR report key: 756172 · Received August 24, 2006

    Report

    Report Number
    2381757-2006-00005
    Event Type
    Other
    Date Received
    August 24, 2006
    Date of Event
    May 31, 2006
    Report Date
    July 26, 2006
    Manufacturer
    KIMBERLY-CLARK CORP,CONSUMER PRODUCTS MILL
    Product Code
    HEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE INFUSION PUMP WAS TESTED FOR FLOW ACCURACY AT 100 ML/HOUR, THE INFUSION PUMP FAILED THE ACCURACY TEST WITH A FLOW VALUE OF -8.5% FROM THE DESIRED AMOUNT. THE SPECIFICATION OF THIS DEVICE IS +/-5%. THIS ISSUE IS CURRENTLY BEING INVESTIGATED UNDER MDQ-CAPA-164.

    Description of Event or Problem · 1

    KIMBERLY-CLARK CORP. RECEIVED NOTICE ON 7/26/06 THAT THE SUBJECT HAD TO VISIT HER DR IN 2006, TO HAVE A TAMPON, FROM WHICH THE REMOVAL STRING HAD SEPARATED, REMOVED. SHE ALLEGED THAT SHE WENT TO THE DR BECAUSE SHE WAS FEELING SOME DIZZINESS. A CULTURE WAS TAKEN AND THE PT WAS PRESCRIBED ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KOTEX SECURITY TAMPON (SUPER) UNSCENTED MESTRUAL TAMPON HEB KIMBERLY-CLARK CORP,CONSUMER PRODUCTS MILL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other