BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENSTRUAL PAD (UNSPECIFIED)

    MDR report key: 22995032 · Received September 8, 2025

    Report

    Report Number
    3014829931-2025-00005
    Event Type
    Injury
    Date Received
    September 8, 2025
    Report Date
    September 8, 2025
    Manufacturer
    SHANGHAI 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, NO SPECIFIC MENSTRUAL PAD PRODUCT NOR LOT CODE WAS REPORTED BY THE CONSUMER. THEREFORE, A DOCUMENTATION REVIEW WAS PERFORMED ON THE HONEY POT COMPANY'S TOP-SELLING MENSTRUAL PAD PRODUCT. THIS REVIEW WAS PERFORMED ON THE HONEY POT COMPANY'S ORGANIC TOP SHEET HERBAL REGULAR PADS. QC INSPECTION RECORDS OF (B)(4) LOTS MANUFACTURED IN 2025 OF THE ORGANIC TOP SHEET HERBAL REGULAR PADS WERE REVIEWED AND IT WAS CONFIRMED THAT ALL IN-PROCESS CHECKS WERE PERFORMED, AND THE RESULTS OF THOSE CHECKS WERE IN COMPLIANCE WITH THE SPECIFICATION.

    Description of Event or Problem · 0

    ON 18-MAY-2025, A SPONTANEOUS REPORT WAS RECEIVED VIA EMAIL REGARDING A FEMALE CONSUMER OF UNSPECIFIED AGE WHO USED AN UNSPECIFIED THE HONEY POT PAD. AN ADDITIONAL EMAIL ON BEHALF OF THIS CONSUMER WAS RECEIVED ON (B)(6) 2025. BOTH CONTACTS WILL BE TREATED AS AN INITIAL REPORT. ON AN UNSPECIFIED DATE, THE CONSUMER BEGAN USING THE HONEY POT UNSPECIFIED PAD AT AN UNKNOWN FREQUENCY. NO LOT NUMBER OR EXPIRATION DATE WAS PROVIDED. ON AN UNSPECIFIED DATE AFTER USING THE PRODUCT, SHE DEVELOPED CHEMICAL BURNS CAUSING VAGINAL EROSION AND AN INVASIVE YEAST INFECTION REQUIRING HOSPITALIZATION. AS OF (B)(6) 2025, SHE REMAINED HOSPITALIZED. NO FURTHER CLINICAL DETAILS WERE PROVIDED. AT THE TIME OF REPORTING, NO FURTHER INFORMATION WAS AVAILABLE. ADDITIONAL ATTEMPTS TO REACH THE CONSUMER VIA EMAIL ON (B)(6) 2025 TO ASCERTAIN ADDITONAL CASE DETAILS WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2441123 MENSTRUAL PAD (UNSPECIFIED) PAD, MENSTRUAL HHL SHANGHAI SHUXIAO INDUSTRY CO.,LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| H