BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPER COOLING PAD

    MDR report key: 25033519 · Received April 29, 2026

    Report

    Report Number
    3014829931-2026-00001
    Event Type
    Injury
    Date Received
    April 29, 2026
    Report Date
    April 29, 2026
    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, ORGANIC TOP SHEET HERBAL SUPER PADS LOT CODE 251220-8742 COA WAS REVIEWED AND CONFIRMED ALL TESTING MET SPECIFICATIONS AND QUALITY COMPLIANCE WAS CONFIRMED.

    Description of Event or Problem · 0

    ON 17-APR-2026, THIS SPONTANEOUS REPORT WAS RECEIVED FROM A CONSUMER VIA EMAIL REGARDING A FEMALE CONSUMER (AGE NOT PROVIDED) IN ASSOCIATION WITH A SUPER COOLING PAD. ON AN UNSPECIFIED DATE, THE CONSUMER APPLIED A SUPER COOLING PAD TOPICALLY. AFTER TWO DAYS OF USING THE PRODUCT, HER HEMORRHOID BECAME INFLAMED. SHE THOUGHT IT WAS DUE TO THE CHEMICALS IN THE PAD. SHE DID NOT THINK THE SCENT SHOULD BE IN THE PAD. ON AN UNSPECIFIED DATE SHE WENT TO HER DOCTOR'S OFFICE. SHE ANTICIPATED SEEING A SURGEON ON (B)(6) 2026. FOLLOW UP WAS UNSUCCESSFUL IN OBTAINING ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    557545 SUPER COOLING PAD PAD, MENSTRUAL, SCENTED HHL SHANGHAI SHUXIAO INDUSTRY CO.,LTD 251220

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention