BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAYFREE CLEAN

    MDR report key: 928364 · Received October 16, 2007

    Report

    Report Number
    8022269-2007-00011
    Event Type
    Injury
    Date Received
    October 16, 2007
    Date of Event
    September 11, 2007
    Report Date
    October 16, 2007
    Manufacturer
    JOHNSON & JOHNSON, INC.
    Product Code
    HHL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS RE-ASSESSED BY THE MEDICAL REVIEWER AND DETERMINED TO BE A REPORTABLE EVENT.

    Description of Event or Problem · 1

    CONSUMER ALLEGED THAT WHEN SHE APPLIED THE PRODUCT, SHE DEVELOPED SECOND DEGREE BURNS, CONTACT DERMATITIS, SWELLING, PAIN AND REDNESS ON EXTERNAL VAGINAL AREA. SHE WAS TREATED BY HER PHYSICIAN WITH A&D OINTMENT AND SITZ BATHS. SYMPTOMS HAVE NOT ABATED. NO FURTHER INFORMATION WAS GIVEN. THIS CLOSES THIS REPORT UNLESS ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAYFREE CLEAN MENSTRUAL PAD PLUS CLEANSING WIPE HHL JOHNSON & JOHNSON, INC. NA 2085NBW

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention