BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HERBAL PAD

    MDR report key: 16430338 · Received February 23, 2023

    Report

    Report Number
    3014829931-2023-00001
    Event Type
    Injury
    Date Received
    February 23, 2023
    Date of Event
    January 14, 2023
    Report Date
    February 17, 2023
    Manufacturer
    SHUXIAO INDUSTRY CO.,LTD
    Product Code
    HHL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    FOR THIS INVESTIGATION, ORGANIC TOP SHEET HERBAL REGULAR PADS LOT CODE 220421-8728 COA WAS REVIEWED AND CONFIRMED ALL TESTING MET SPECIFICATIONS AND WAS COMPLIANCE. A DIFFERENT IN MARKET LOT (220416-8728) WHICH WAS IN THE SAME CAMPAIGN AS THE LOT IN QUESTION (MANUFACTURED 5 DAYS EARLIER) WAS INVESTIGATED FOR QUALITY COMPLIANCE BY THE CONTRACT MANUFACTURER. QUALITY COMPLIANCE WAS CONFIRMED, AND LOT TESTED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 0

    ON (B)(6) 2023, A SPONTANEOUS REPORT FROM THE UNITED STATES WAS RECEIVED VIA EMAIL REGARDING A 44-YEAR-OLD FEMALE WHO USED AN UNSPECIFIED HERBAL PAD. NO MEDICAL HISTORY WAS PROVIDED. CONCOMITANT PRODUCTS INCLUDED UNSPECIFIED SUPPLEMENTS. ON THE NIGHT OF (B)(6) 2023, THE CONSUMER APPLIED AN HERBAL PAD. A COUPLE OF SECONDS AFTER USING THE PAD, SHE FELT UNCOMFORTABLE. SHE COULD ONLY WEAR IT FOR 2 TO 5 MINUTES DUE TO INTENSE PAIN. IT WAS VERY PAINFUL, AND IT BURNED. SUBSEQUENTLY, THEN SHE TOOK A SHOWER. THE SHOWER DID NOT HELP, AND IT WAS UNCOMFORTABLE TO SIT. SHE DID NOT USE THE PRODUCT ANYMORE. ON (B)(6) 2023, HER SYMPTOMS DID NOT IMPROVE SO SHE WENT TO A DOCTOR. THE DOCTOR TOLD HER THAT HER LABIA WAS BURNED ON THE INSIDE AND OUTSIDE. SHE WAS PRESCRIBED A STEROID CREAM AND DIFLUCAN (FLUCONAZOLE) TABLETS. ON (B)(6) 2023, SHE FINISHED THE DIFLUCAN, BUT SHE DID NOT START THE STEROID CREAM DUE TO COST. AS OF (B)(6) 2023, SHE HER BURN WAS STILL PAINFUL AND UNCOMFORTABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449505 HERBAL PAD PAD, MENSTRUAL, SCENTED HHL SHUXIAO INDUSTRY CO.,LTD 220421-8728

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female Required Intervention UNSPECIFIED SUPPLEMENTS