BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLAYTEX SPORT REGULAR UNSCENTED TAMPONS

    MDR report key: 4938155 · Received July 22, 2015

    Report

    Report Number
    2515444-2015-00002
    Event Type
    Injury
    Date Received
    July 22, 2015
    Date of Event
    April 3, 2015
    Report Date
    July 17, 2015
    Manufacturer
    PLAYTEX MANUFACTUING, INC.
    Product Code
    HEB
    PMA / PMN Number
    K132819
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6), EDGEWELL PERSONAL CARE BRANDS, LLC (FORMERLY ENERGIZER PERSONAL CARE, LLC) REC'D A CALL FROM THE CONSUMER'S MOTHER REPORTING THAT ON (B)(6), HER DAUGHTER DEVELOPED SYMPTOMS OF FEVER, PALENESS, VOMITING AND ABDOMINAL PAIN. THE DAUGHTER WAS 2-3 DAYS INTO HER MENSES AND HER MOTHER WAS ADMINISTERING TYLENOL AND MOTRIN. THE FOLLOWING DAY, (B)(6), THE DAUGHTER FELT WORSE SO SHE WAS TAKEN TO TWO WALK-IN CLINICS WHERE SHE WAS ADVISED TO GO TO AN EMERGENCY ROOM. THE DAUGHTER WAS ADMITTED TO A HOSPITAL FOR EVAL AND TREATMENT. THE MOTHER SAYS HER DAUGHTER WAS DIAGNOSED WITH TOXIC SHOCK SYNDROME AND WAS HOSPITALIZED FOR A TOTAL OF SIX DAYS. SHE STATED THAT NO ADDITIONAL TREATMENT OR FOLLOW-UP CARE IS NEEDED, BUT HER DAUGHTER IS NOW DEPRESSED AND SUICIDAL AND IS TAKING MEDICATION FOR DEPRESSION. EDGEWELL HAS NOT REC'D MEDICAL RECORDS FOR THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475717 PLAYTEX SPORT REGULAR UNSCENTED TAMPONS MENSTRUAL TAMPON HEB PLAYTEX MANUFACTUING, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Hospitalization