BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLAYTEX, GENTLE GLIDE, REGULAR, NON-DEODORANT, TAMPONS

    MDR report key: 1031576 · Received January 9, 2008

    Report

    Report Number
    2515444-2007-00019
    Event Type
    Malfunction
    Date Received
    January 9, 2008
    Date of Event
    December 1, 2007
    Report Date
    January 8, 2008
    Manufacturer
    PLAYTEX PRODUCTS, INC.
    Product Code
    HEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE REQUESTED AND AWAIT THE CONSUMER'S RETURN OF PRODUCT FOR EVALUATION AND DATE CODE INFO FOR INVESTIGATION.

    Description of Event or Problem · 1

    RECEIVED A REPORT FROM A CONSUMER INDICATING ON SEVERAL OCCASIONS WITH ONE PARTICULAR BOX OF TAMPONS, SHE EXPERIENCED A PIECE OF THE PLEDGET SEPARATING DURING REMOVAL OF THE TAMPON. CONSUMER ADVISED SHE WOULD THEN USED A PAD, AND THE PIECE WOULD EXPEL ON ITS OWN A SHORT TIME LATER. CONSUMER FURTHER ADVISED, SHE HAS USED THIS BRAND BEFORE WITHOUT INCIDENT. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLAYTEX, GENTLE GLIDE, REGULAR, NON-DEODORANT, TAMPONS TAMPON HEB PLAYTEX PRODUCTS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR