BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HERBAL PANTILINER

    MDR report key: 18867917 · Received March 8, 2024

    Report

    Report Number
    3014829931-2024-00001
    Event Type
    Injury
    Date Received
    March 8, 2024
    Report Date
    March 5, 2024
    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 HERBAL MENSTRUAL LINER LOT CODE WAS REPORTED BY THE CONSUMER. THEREFORE, A DOCUMENTATION REVIEW ON HERBAL MENSTRUAL LINERS WAS PERFORMED ACROSS 11 LOTS MANUFACTURED IN 2023 AND 2024. QC INSPECTION RECORDS OF THE 11 LOTS MANUFACTURED IN 2023 AND 2024 OF 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

    ON 15-FEB-2024 A SPONTANEOUS REPORT WAS RECEIVED FROM THE UNITED STATES REGARDING A FEMALE CONSUMER (AGE NOT PROVIDED) WHO USED AN UNSPECIFIED HERBAL PANTILINER. ON AN UNSPECIFIED DATE, THE CONSUMER TOPICALLY APPLIED AN UNSPECIFIED HERBAL PANTILINER FOR AN UNSPECIFIED INDICATION. ON AN UNSPECIFIED DATE AFTER APPLYING THE PRODUCT, THE CONSUMER EXPERIENCED AN ALLERGIC REACTION WHICH RESULTED IN A BACTERIAL INFECTION AFTER WEARING ONE PANTILINER. ON AN UNSPECIFIED DATE THE CONSUMER TALKED TO HER DOCTOR OF OBSTETRICS AND GYNECOLOGY. SHE HAD TO TAKE TOPICAL MEDICATIONS AND HAD TO SPEND MONEY ON MEDICATIONS (NOT FURTHER SPECIFIED). AFTER TWO WEEKS, SHE STARTED HEALING. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160964 HERBAL PANTILINER PAD, MENSTRUAL, SCENTED HHL SHANGHAI SHUXIAO INDUSTRY CO.,LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention