BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLAYTEX, GENTLE GLIDE, SUPER, UNSCENTED TAMPONS

    MDR report key: 1182646 · Received September 24, 2008

    Report

    Report Number
    2515444-2008-00006
    Event Type
    Malfunction
    Date Received
    September 24, 2008
    Date of Event
    August 28, 2008
    Report Date
    September 24, 2008
    Manufacturer
    PLAYTEX PRODUCTS, INC.
    Product Code
    HEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE REQUESTED AND AWAITED 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 A PORTION OF THE TAMPON PLEDGET SEPARATED DURING REMOVAL OF THE TAMPON. CONSUMER WAS ABLE TO REMOVE MOST OF THE REMAINING PIECE DIGITALLY, AND SHE ADVISED SHE WOULD SEEK MEDICAL ASSISTANCE FOR REMOVAL OF THE REMAINING PIECE ONLY IF IT DID NOT EXPEL BY ITSELF. NO INJURY REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1