BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O.B. NON-APPLICATOR REGULAR TAMPON

    MDR report key: 1203445 · Received October 17, 2008

    Report

    Report Number
    8022269-2008-00003
    Event Type
    Malfunction
    Date Received
    October 17, 2008
    Date of Event
    April 1, 2008
    Report Date
    September 19, 2008
    Manufacturer
    JOHNSON & JOHNSON, INC.
    Product Code
    HEB
    PMA / PMN Number
    K974629
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT TRENDS MONITORED. THIS REPORT IS CONSIDERED CLOSED UNLESS ADD'L RELEVANT INFO IS RECEIVED.

    Description of Event or Problem · 1

    CONSUMER REPORTED THAT, FOR THE PAST 6 MONTHS, SHE HAS NOTICED THAT THE TAMPONS SEEM TO FALL APART IN USE, LEAVING BEHIND STRANDS OF 'COTTON' THAT NEED TO BE REMOVED BY HAND OR WITH TWEEZERS. SHE REPORTED THAT THE PROBLEM OCCURS WITH THE REGULAR ABSORBENCY, BUT NOT THE SUPER ABSORBENCY TAMPONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 O.B. NON-APPLICATOR REGULAR TAMPON UNSCENTED MENSTRUAL TAMPON HEB JOHNSON & JOHNSON, INC. NA 1818M0056

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR