BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIDOL HEAT VIBES

    MDR report key: 17844467 · Received September 29, 2023

    Report

    Report Number
    3000206585-2023-00009
    Event Type
    Injury
    Date Received
    September 29, 2023
    Report Date
    October 2, 2023
    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). THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER THROUGH SOCIAL MEDIA AND DESCRIBES THE OCCURRENCE OF THERMAL BURN ("IT BURNED MY SKIN") IN A PATIENT WHO RECEIVED MIDOL HEAT VIBES MEDICATED PLASTER (LOT 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 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 BAYER INTERNAL REVIEW : CASE UPGRADED DUE TO SERIOUSNESS CRITERIA ADDED FOR EVENT "IT BURNED MY SKIN". NO NEW FOLLOW-UP INFORMATION WAS RECEIVED FROM THE REPORTER. FURTHER COMPANY FOLLOW-UP WITH THE CONSUMER OR THE REPORTER IS NOT POSSIBLE. 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.

    Description of Event or Problem · 0

    BAYER CASE NUMBER: (B)(4). THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER THROUGH SOCIAL MEDIA AND DESCRIBES THE OCCURRENCE OF THERMAL BURN ("IT BURNED MY SKIN") IN A PATIENT WHO RECEIVED MIDOL HEAT VIBES MEDICATED PLASTER (LOT 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 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, BECAUSE THE BATCH NUMBER IS UNKNOWN, A BATCH RECORD REVIEW COULD NOT BE PERFORMED. A REVIEW OF PRIOR COMPLAINTS WITH REPORTS OF BURN WERE EITHER FOUND TO BE A RESULT TO OF INCORRECT USAGE OR LACK OF INFORMATION PROVIDED BY THE REPORTER. AN INTERNAL INVESTIGATION WAS PERFORMED ON BATCH NUMBERS REPORTED IN PREVIOUS COMPLAINTS WITH REPORTS OF BURN AND IT WAS DETERMINED THAT THE AVERAGE TEMPERATURE OF THE RETAIN SAMPLES WERE WITH SPECIFIED CRITERIA. BASED ON THE ASSESSMENT OF THE PROVIDED INFORMATION, A ROOT CAUSE CANNOT BE DETERMINED. IT IS IMPORTANT TO NOTE THAT INDIVIDUAL PERCEPTIONS OF THE PRODUCT'S HEAT SENSATIONS CAN VARY WIDELY. FACTORS, SUCH AS PATCH PLACEMENT, SKIN INTERACTIONS, USER ACTIVITY AND CLOTHING TYPE CAN INFLUENCE HOW A CONSUMER PERCEIVES THE PRODUCT. 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 EVENTS AND A QUALITY DEFECT. THE REPORTED EVENTS ARE 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: 29-SEP-2023: QUALITY-SAFETY EVALUATION OF PTC : UNCONFIRMED QUALITY DEFECT, NO DEFECT. UPDATE OF GLOBAL PTC NUMBER. FURTHER COMPANY FOLLOW-UP WITH THE CONSUMER OR THE REPORTER IS NOT POSSIBLE. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED(UNCONFIRMED QUALITY DEFECT); ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353029 MIDOL HEAT VIBES PACK, HOT OR COLD, DISPOSABLE IMD WOOSHIN LABOTTACH CO., LTD. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other