BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIDOL HEAT VIBES

    MDR report key: 24777675 · Received April 3, 2026

    Report

    Report Number
    3000206585-2026-00006
    Event Type
    Injury
    Date Received
    April 3, 2026
    Report Date
    April 27, 2026
    Manufacturer
    WOOSHIN LABOTTACH, CO, LTD
    Product Code
    IMD
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    BAYER CASE NUMBER: (B)(4). RECEIVED BURNS ON LOWER ABDOMEN [BURN OF UNSPECIFIED DEGREE OF ABDOMINAL WALL] . CASE NARRATIVE: THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER THROUGH SOCIAL MEDIA AND DESCRIBES THE OCCURRENCE OF THERMAL BURN ("RECEIVED BURNS ON LOWER ABDOMEN") IN A PATIENT WHO RECEIVED MIDOL HEAT VIBES MEDICATED PLASTER (LOT NO. UNK) FOR PRODUCT USED FOR UNKNOWN INDICATION. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON AN UNKNOWN DATE, THE PATIENT STARTED MIDOL HEAT VIBES (UNKNOWN) AT AN UNSPECIFIED DOSE AND FREQUENCY. ON AN UNKNOWN DATE THE PATIENT EXPERIENCED THERMAL BURN (SERIOUSNESS CRITERION MEDICALLY IMPORTANT). IT WAS UNKNOWN WHETHER ANY ACTION WAS TAKEN WITH MIDOL HEAT VIBES. THE REPORTER CONSIDERED THERMAL BURN TO BE RELATED TO MIDOL HEAT VIBES ADMINISTRATION. CASE COMMENTS: BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT. IN CASE A SAMPLE IS RECEIVED THE INVESTIGATION MIGHT LEAD TO DESTRUCTION OF THE SAMPLE IF REQUIRED TO PERFORM A PROPER ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62987 MIDOL HEAT VIBES PACK, HOT OR COLD, DISPOSABLE IMD WOOSHIN LABOTTACH, CO, LTD UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other