BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLAYTEX, GENTLE GLIDE, MULTI-PACK, FRESH SCENT TAMPONS

    MDR report key: 1211292 · Received October 21, 2008

    Report

    Report Number
    2515444-2008-00008
    Event Type
    Malfunction
    Date Received
    October 21, 2008
    Date of Event
    September 23, 2008
    Report Date
    October 21, 2008
    Manufacturer
    PLAYTEX PRODUCTS, INC.
    Product Code
    HIL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAD REQUESTED AND RECEIVED THE CONSUMER'S RETURN OF PRODUCT FOR EVALUATION. WE HAD REQUESTED THE RETURN OF THE LOT CODE INFORMATION AND THE CONSUMER HAD PROVIDED THE PACKAGING, HOWEVER, THE CONSUMER HAD COVERED THE LOT CODE WITH A SHIPPING LABEL AND SHIPPING TAPE, RENDERING THE LOT CODE ILLEGIBLE. WE HAVE SENT THE PROVIDED PRODUCT AND INITIALLY ADVISED LOT CODE INFORMATION TO QA FOR INVESTIGATION. WE AWAIT THE RESULTS.

    Description of Event or Problem · 1

    RECEIVED A REPORT FROM A CONSUMER INDICATING SHE EXPERIENCED DISCOMFORT WHILE REMOVING A TAMPON PLEDGET, AND WAS CONCERNED A PIECE OF THE PLEDGET MAY HAVE BEEN LEFT BEHIND. NO INJURY REPORTED, AND LATER CORRESPONDENCE RECEIVED FROM CONSUMER INDICATED SHE RECOVERED FROM SAID EXPERIENCE WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLAYTEX, GENTLE GLIDE, MULTI-PACK, FRESH SCENT TAMPONS TAMPON HIL PLAYTEX PRODUCTS, INC. NA 533AB

    Patients

    Seq Age Sex Outcome Treatment
    1