BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIDOL HEAT VIBES

    MDR report key: 23276918 · Received October 15, 2025

    Report

    Report Number
    3000206585-2025-00005
    Event Type
    Injury
    Date Received
    October 15, 2025
    Report Date
    October 24, 2025
    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). SECOND DEGREE BURNS ON TUMMY [SECOND DEGREE BURNS]. CASE NARRATIVE: THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER THROUGH SOCIAL MEDIA AND DESCRIBES THE OCCURRENCE OF BURNS SECOND DEGREE ("SECOND DEGREE BURNS ON TUMMY") IN A PATIENT WHO RECEIVED MIDOL HEAT VIBES MEDICATED PLASTER (BATCH NO. UNKNOWN). THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON AN UNKNOWN DATE, THE PATIENT STARTED MIDOL HEAT VIBES AT AN UNSPECIFIED DOSE AND FREQUENCY. ON AN UNKNOWN DATE THE PATIENT EXPERIENCED BURNS SECOND DEGREE (SERIOUSNESS CRITERION MEDICALLY IMPORTANT). IT WAS UNKNOWN WHETHER ANY ACTION WAS TAKEN WITH MIDOL HEAT VIBES. AT THE TIME OF THE REPORT, THE OUTCOME OF THE EVENT WAS UNKNOWN. THE REPORTER CONSIDERED BURNS SECOND DEGREE 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.

    Description of Event or Problem · 0

    BAYER CASE NUMBER: (B)(4) SECOND DEGREE BURNS ON TUMMY [SECOND DEGREE BURNS] . CASE NARRATIVE: THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER THROUGH SOCIAL MEDIA AND DESCRIBES THE OCCURRENCE OF BURNS SECOND DEGREE ("SECOND DEGREE BURNS ON TUMMY") IN A PATIENT WHO RECEIVED MIDOL HEAT VIBES MEDICATED PLASTER (BATCH NO. UNKNOWN). THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON AN UNKNOWN DATE, THE PATIENT STARTED MIDOL HEAT VIBES AT AN UNSPECIFIED DOSE AND FREQUENCY. ON AN UNKNOWN DATE THE PATIENT EXPERIENCED BURNS SECOND DEGREE (SERIOUSNESS CRITERION MEDICALLY IMPORTANT). IT WAS UNKNOWN WHETHER ANY ACTION WAS TAKEN WITH MIDOL HEAT VIBES. AT THE TIME OF THE REPORT, THE OUTCOME OF THE EVENT WAS UNKNOWN. THE REPORTER CONSIDERED BURNS SECOND DEGREE TO BE RELATED TO MIDOL HEAT VIBES ADMINISTRATION. QUALITY-SAFETY EVALUATION OF PTC: FOR MIDOL HEAT VIBES: AN IN-DEPTH PTC INVESTIGATION CANNOT BE CONDUCTED BY THE QUALITY UNIT AS NEITHER A BATCH NUMBER NOR SAMPLE WAS PROVIDED. A QUALITY DEFECT COULD NOT BE CONFIRMED. THEREFORE, THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP BETWEEN THE REPORTED EVENT AND A QUALITY DEFECT. THE REPORTED EVENT IS NOT INDICATIVE OF A QUALITY DEFICIT PER SE. THIS COMPLAINT IS SUBJECT TO ROUTINE SIGNALING, TRENDING ACCORDING TO ESTABLISHED PROCEDURES. ANY NEED FOR A CORRECTIVE AND/OR PREVENTIVE ACTION IS DETERMINED IN RESPONSE TO THE RESPECTIVE SIGNAL. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 22-OCT-2025: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT WAS RECEIVED. CASE COMMENTS: BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS 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
    180215 MIDOL HEAT VIBES PACK, HOT OR COLD, DISPOSABLE IMD WOOSHIN LABOTTACH, CO, LTD UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other