BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALWAYS/NATURELLA/ORKID/ONLY YOU PAD, SCENTED

    MDR report key: 3975147 · Received July 1, 2014

    Report

    Report Number
    9680085-2014-00001
    Event Type
    Injury
    Date Received
    July 1, 2014
    Report Date
    May 30, 2014
    Manufacturer
    PROCTER & GAMBLE GMBH & CO.
    Product Code
    HHL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    A LOT NUMBER WAS PROVIDED BY THE REPORTER, LOT CHECK AND BATCH RETAIN TESTING PENDING.

    Description of Event or Problem · 1

    ECZEMA ON GENITAL SKIN - FEMALE [ECZEMA]. RASH-VAGINA [VULVOVAGINAL RASH]. CASE DESCRIPTION: A CONSUMER REPORTED THAT THEY, A FEMALE AGE UNSPECIFIED, USED ALWAYS PADS ULTRA ACTIPEARLS WING REGULAR NORMAL 1 APPLIC, DAILY BEGINNING (B)(6) 2013 AND REPORTED THE FOLLOWING: ECZEMA ON FEMALE GENITAL SKIN AND VAGINAL RASH. THE CONSUMER WAS ADMITTED TO THE HOSPITAL FOR 2 WEEKS. TREATMENT: CORTISONE, OINTMENT. THE CASE OUTCOME WAS NOT RECOVERED/NOT RESOLVED. THE CONSUMER WAS ADVISED TO DISCONTINUE USE OF THE PRODUCT BUT SHE CONTINUED TO USE THE ALWAYS PADS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381801 ALWAYS/NATURELLA/ORKID/ONLY YOU PAD, SCENTED NONE HHL PROCTER & GAMBLE GMBH & CO. 32710314191435

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O