BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIDOL HEAT VIBES

    MDR report key: 23070804 · Received September 17, 2025

    Report

    Report Number
    3000206585-2025-00003
    Event Type
    Injury
    Date Received
    September 17, 2025
    Date of Event
    August 13, 2025
    Report Date
    September 18, 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) FELT BURNING PAIN AND WHEN SHE LOOKED, SHE SAW THREE SEPARATE SMALL BURNS ON HER LOWER ABDOMEN [THERMAL BURN] . CASE NARRATIVE: THIS SPONTANEOUS CASE WAS REPORTED BY A FAMILY MEMBER AND DESCRIBES THE OCCURRENCE OF THERMAL BURN ("FELT BURNING PAIN AND WHEN SHE LOOKED, SHE SAW THREE SEPARATE SMALL BURNS ON HER LOWER ABDOMEN") IN A 19-YEAR-OLD FEMALE PATIENT WHO RECEIVED MIDOL HEAT VIBES MEDICATED PLASTER (BATCH NO. BU23049) FOR DYSMENORRHOEA. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON (B)(6) 2025 THE PATIENT STARTED MIDOL HEAT VIBES (UNKNOWN) AT AN UNSPECIFIED DOSE AND FREQUENCY. ON (B)(6) 2025, THE DAY OF MIDOL HEAT VIBES INITIATION, SHE EXPERIENCED THERMAL BURN (SERIOUSNESS CRITERION MEDICALLY IMPORTANT). MIDOL HEAT VIBES WAS WITHDRAWN. AT THE TIME OF THE REPORT, THE EVENT WAS RESOLVING. THE REPORTER CONSIDERED THERMAL BURN TO BE RELATED TO MIDOL HEAT VIBES ADMINISTRATION. THE FOLLOWING AMENDMENT WAS MADE: UPON INTERNAL REVIEW EVENT "FELT BURNING PAIN AND WHEN SHE LOOKED, SHE SAW THREE SEPARATE SMALL BURNS ON HER LOWER ABDOMEN" RECODED TO "THERMAL BURN". INDICATION FOR SUSPECT PRODUCT WAS ALSO UPDATED. NO NEW FOLLOW-UP INFORMATION WAS RECEIVED FROM THE REPORTER. CASE COMMENTS: A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT 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) FELT BURNING PAIN AND WHEN SHE LOOKED, SHE SAW THREE SEPARATE SMALL BURNS ON HER LOWER ABDOMEN [THERMAL BURN], FELT BURNING PAIN AND WHEN SHE LOOKED, SHE SAW THREE SEPARATE SMALL BURNS ON HER LOWER ABDOMEN [LOWER ABDOMINAL PAIN] . CASE NARRATIVE: THIS SPONTANEOUS CASE WAS REPORTED BY A FAMILY MEMBER AND DESCRIBES THE OCCURRENCE OF THERMAL BURN ("FELT BURNING PAIN AND WHEN SHE LOOKED, SHE SAW THREE SEPARATE SMALL BURNS ON HER LOWER ABDOMEN") IN A 19-YEAR-OLD FEMALE PATIENT WHO RECEIVED MIDOL HEAT VIBES MEDICATED PLASTER (BATCH NO. BU23049) FOR DYSMENORRHOEA. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON (B)(6) 2025 THE PATIENT STARTED MIDOL HEAT VIBES (UNKNOWN) AT AN UNSPECIFIED DOSE AND FREQUENCY. ON (B)(6) 2025, THE DAY OF MIDOL HEAT VIBES INITIATION, SHE EXPERIENCED THERMAL BURN (SERIOUSNESS CRITERION MEDICALLY IMPORTANT) AND ABDOMINAL PAIN LOWER ("FELT BURNING PAIN AND WHEN SHE LOOKED, SHE SAW THREE SEPARATE SMALL BURNS ON HER LOWER ABDOMEN"). MIDOL HEAT VIBES WAS WITHDRAWN. AT THE TIME OF THE REPORT, ALL OF THE EVENTS WERE RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER AND THERMAL BURN TO BE RELATED TO MIDOL HEAT VIBES ADMINISTRATION. QUALITY-SAFETY EVALUATION OF PTC: FOR MIDOL HEAT VIBES: BASED ON TECHNICAL INVESTIGATION, THE 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. PHOTOS WERE PROVIDED ILLUSTRATING THE COMPLAINANT'S ABDOMINAL SKIN AREA. THIS IS THE FIRST COMPLAINT FOR THE BATCH RELATED WITH THE REPORTED DEFECT. A THOROUGH REVIEW OF THE BATCH RECORD AND CERTIFICATE OF ANALYSIS (COA) FOR BATCH NO. BU23049 CONFIRMED THAT THE PRODUCT MET ALL QUALITY SPECIFICATIONS INDICATING NO PRODUCTION OR QUALITY-RELATED ISSUES. NO COMPLAINT SAMPLE WAS RECEIVED FOR INVESTIGATION BY RESPONSIBLE QUALITY UNIT (RQU). 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. 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. 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: 17-SEP-2025: QUALITY-SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT WAS RECEIVED. AMENDMENT: EVENT "EVENT "FELT BURNING PAIN AND WHEN SHE LOOKED, SHE SAW THREE SEPARATE SMALL BURNS ON HER LOWER ABDOMEN" WAS SPLIT CODED TO MEDDRA PT ABDOMINAL PAIN LOWER ". CASE COMMENTS: A TECHNICAL INVESTIGATION WAS CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1732000 MIDOL HEAT VIBES PACK, HOT OR COLD, DISPOSABLE IMD WOOSHIN LABOTTACH, CO, LTD BU23049

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Female Other