BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HERBAL MENSTRUAL PAD

    MDR report key: 17695110 · Received September 6, 2023

    Report

    Report Number
    3014829931-2023-00007
    Event Type
    Injury
    Date Received
    September 6, 2023
    Report Date
    August 28, 2023
    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 OF ONE OF THE HONEY POT COMPANY'S TOP-SELLING MENSTRUAL PAD PRODUCTS. THIS REVIEW WAS PERFORMED ON THE HONEY POT COMPANY'S ORGANIC TOP SHEET HERBAL REGULAR PADS. QC INSPECTION RECORDS OF 15 LOTS MANUFACTURED IN 2022 AND 2023 OF THE ORGANIC TOP SHEET HERBAL REGULAR PADS WERE REVIEWED AND IT WAS CONFIRMED ALL IN PROCESS CHECKS WERE PERFORMED, AND THE RESULTS OF THOSE CHECKS WERE IN COMPLIANCE WITH THE SPECIFICATION.

    Description of Event or Problem · 0

    THIS SPONTANEOUS REPORT WAS RECEIVED VIA EMAIL ON (B)(6) 2023 FROM A 42-YEAR-OLD, FEMALE CONSUMER REGARDING HER USE OF HONEY POT HERBAL PADS. ON AN UNSPECIFIED DATE, THE CONSUMER SLEPT WITH AN HERBAL PAD IN PLACE FOR THE FIRST TIME. UPON WAKING, SHE REPORTED THAT SHE WAS "BLISTERED" AND HAD A LARGE "KNOT" ON HER VULVA. SHE STATED THAT SHE WAS EVALUATED IN AN URGENT CARE FACILITY ON AN UNSPECIFIED DATE AND WAS ULTIMATELY DIAGNOSED WITH A URINARY TRACT INFECTION AS WELL AS A VAGINAL YEAST INFECTION. AN UNSPECIFIED ANTIBIOTIC WAS REQUIRED TO TREAT THE URINARY TRACT INFECTION AND ANOTHER UNSPECIFIED MEDICATION WAS REQUIRED TO TREAT THE YEAST INFECTION. ADDITIONALLY, THE CONSUMER REPORTED VAGINAL DISCOMFORT THAT HAD YET TO RESOLVE AT THE TIME OF REPORTING. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1123320 HERBAL MENSTRUAL PAD PAD, MENSTRUAL, SCENTED HHL SHANGHAI SHUXIAO INDUSTRY CO.,LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female Required Intervention