BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAREFREE BODY SHAPE LONG PANTILINERS

    MDR report key: 936641 · Received November 1, 2007

    Report

    Report Number
    8022269-2007-00012
    Event Type
    Injury
    Date Received
    November 1, 2007
    Date of Event
    May 1, 2007
    Report Date
    October 31, 2007
    Manufacturer
    JOHNSON & JOHNSON, INC.
    Product Code
    HHL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CONSUMER INFORMATION CENTER RECEIVED A COMPLAINT ON OCTOBER 22, 2007. CONSUMER REPORTED THAT SHE USED THE PRODUCT SEVERAL TIMES SINCE APPROXIMATELY 2006. IN 2007, SHE DEVELOPED A URINARY TRACT INFECTION (UTI) THAT LED TO SEPTICEMIA, AND ALMOST DEATH. AT THAT TIME, SHE WAS HOSPITALIZED FOR 10 DAYS. SHE IS UNSURE IF UTI WAS CAUSED FROM THE USE OF PRODUCT. SHE HAS CONTINUED TO USE THE PRODUCT THROUGH THIS MONTH, AND IS NOW EXPERIENCING BURNING IN URINATION, WHICH MAY BE ANOTHER UTI. CONSUMER NO LONGER HAS THE BOX THAT SHE USED IN MAY PRECEDING THE HOSPITALIZATION. HER SYMPTOMS PERSISTS. CONSUMER WAS ADVISED TO DISCONTINUE THE USE OF PRODUCT, AND CONSULT HER PHYSICIAN. CONSUMER INFORMATION CENTER ATTEMPTED TO CONTACT THE CONSUMER ON 10/22/2007. NO RESPONSE BY THE CONSUMER. THIS REPORT IS CLOSED UNLESS NEW, SIGNIFICANT INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAREFREE BODY SHAPE LONG PANTILINERS MENSTRUAL PAD HHL JOHNSON & JOHNSON, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Hospitalization| L| R POTASSIUM SUPPLEMENT| LORAZEPAM| PRESER| VISION| PRILOSEC| ISOSORBIDE| LASIX| PLAVIX| ASA