BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIDOL HEAT VIBES

    MDR report key: 22847421 · Received August 20, 2025

    Report

    Report Number
    3000206585-2025-00002
    Event Type
    Injury
    Date Received
    August 20, 2025
    Report Date
    September 9, 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) BURN ON SKIN ((MIDOL HEAT VIBES) [BURN] CASE NARRATIVE: THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF THERMAL BURN ("BURN ON SKIN ((MIDOL HEAT VIBES)") IN A PATIENT WHO RECEIVED MIDOL HEAT VIBES MEDICATED PLASTER (BATCH NO. BU25008). 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 THERMAL BURN (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 THERMAL BURN TO BE RELATED TO MIDOL HEAT VIBES ADMINISTRATION. QUALITY-SAFETY EVALUATION OF PTC: FOR MIDOL HEAT VIBES: BASED ON TECHNICAL INVESTIGATION, REVIEW OF THE BATCH RECORD INDICATES THERE WERE NO REPORTED INCIDENTS OR DEVIATIONS THAT WOULD LEAD TO THE REPORTED DEFECT. IN-PROCESS TESTING WAS PERFORMED AND WAS WITHIN SPECIFICATIONS. THE BATCH MET THE PRE-DETERMINED ACCEPTANCE CRITERIA FOR RELEASE OF THE PRODUCT TO THE MARKET. RETAIN SAMPLE WAS VISUALLY INSPECTED AND NO ANOMALIES WERE FOUND. THREE PHOTOS OF THE MIDOL HEAT-VIBES FRONT AND BACK OF THE CARTON WERE PROVIDED FOR THIS INVESTIGATION; HOWEVER, THEY DO NOT AID IN THE ROOT CAUSE OF THE COMPLAINT. THIS IS THE FIRST COMPLAINT FOR THE BATCH RELATED WITH THE REPORTED DEFECT. A THOROUGH REVIEW OF THE BATCH RECORD AND CERTIFICATE OF ANALYSIS FOR THIS BATCH CONFIRMED THAT THE PRODUCT MET ALL QUALITY SPECIFICATIONS, INCLUDING THE AVERAGE TEMPERATURE OF RETAINED SAMPLES OVER AN 8-HOUR PERIOD, INDICATING NO PRODUCTION OR QUALITY RELATED ISSUES. HOWEVER, THE COMPLAINT LACKS CRITICAL INFORMATION NECESSARY FOR A COMPREHENSIVE ASSESSMENT, SUCH AS THE EXACT METHOD OF PATCH APPLICATION, THE TYPE OF CLOTHING IT WAS ATTACHED TO, AND WHETHER THE PATCH WAS EXPOSED TO THE EXTERNAL ENVIRONMENT AFTER APPLICATION. IT IS IMPORTANT TO NOTE THAT THE PERCEPTION OF HEAT CAN VARY SIGNIFICANTLY FROM PERSON TO PERSON, DEPENDING ON FACTORS SUCH AS PATCH PLACEMENT, SKIN CONDITION, LEVEL OF PHYSICAL ACTIVITY, AND CLOTHING TYPE. NO COMPLAINT SAMPLE WAS RECEIVED FOR INVESTIGATION BY RESPONSIBLE QUALITY UNIT (RQU). BASED ON THE AVAILABLE INFORMATION, NO PRODUCT QUALITY DEFECT WAS 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: 05-SEP-2025: QUALITY-SAFETY EVALUATION OF PTC WAS RECEIVED. CASE COMMENTS: A TECHNICAL INVESTIGATION WAS CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAIN RECORDS AND OTHER RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS 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). BURN ON SKIN ((MIDOL HEAT VIBES) [BURN]. CASE NARRATIVE: THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF THERMAL BURN ("BURN ON SKIN ((MIDOL HEAT VIBES)") IN A PATIENT WHO RECEIVED MIDOL HEAT VIBES MEDICATED PLASTER (BATCH NO. BU25008). 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 THERMAL BURN (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 THERMAL BURN TO BE RELATED TO MIDOL HEAT VIBES ADMINISTRATION. THE FOLLOWING AMENDMENT WAS MADE: UPON INTERNAL REVIEW EVENT "BURN ON SKIN" WAS UPGRADED TO SERIOUS. NO NEW FOLLOW-UP INFORMATION WAS RECEIVED FROM THE REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1244501 MIDOL HEAT VIBES PACK, HOT OR COLD, DISPOSABLE IMD WOOSHIN LABOTTACH, CO, LTD BU25008

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other