BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KOTEX SECURITY TAMPONS

    MDR report key: 1841537 · Received September 17, 2010

    Report

    Report Number
    3008144662-2010-00003
    Event Type
    Malfunction
    Date Received
    September 17, 2010
    Date of Event
    August 23, 2010
    Report Date
    September 17, 2010
    Manufacturer
    QINGDAO P&B CO., LTD.
    Product Code
    HEB
    PMA / PMN Number
    K896994
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD IN REVIEW. CONSUMER DID NOT RETURN PRODUCT SAMPLES FOR EVALUATION.

    Description of Event or Problem · 1

    ON (B)(6) 2010, CONSUMER STATED A TAMPON PULLED APART AS SHE ATTEMPTED TO REMOVE THE TAMPON FROM HER BODY. ON (B)(6) 2010, CONSUMER'S DOCTOR REMOVED A PIECE OF TAMPON THAT REMAINED INSIDE HER AND PRESCRIBED AN ANTIBIOTIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KOTEX SECURITY TAMPONS HEB - UNSCENTED MENSTRUAL TAMPON HEB QINGDAO P&B CO., LTD. REGULAR ABSORBENCY PB0155AAA1854

    Patients

    Seq Age Sex Outcome Treatment
    1 Other