BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIDOL HEAT VIBES

    MDR report key: 16272459 · Received January 31, 2023

    Report

    Report Number
    3000206585-2023-00001
    Event Type
    Injury
    Date Received
    January 31, 2023
    Date of Event
    January 18, 2023
    Report Date
    August 11, 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 45-YEAR-OLD FEMALE PATIENT WAS IDENTIFIED DURING A MARKET RESEARCH PROGRAM. THE PATIENT RECEIVED MIDOL HEAT VIBES 3CT (BATCH NO. BU22104) FOR PAIN. THE CASE DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE SITE BURN ('IT BURNT MY STOMACH'). FROM (B)(6) 2023 UNTIL (B)(6) 2023, THE PATIENT RECEIVED MIDOL HEAT VIBES 3CT, 2 PATCHES. ON (B)(6) 2023, THE PATIENT EXPERIENCED MEDICAL DEVICE SITE BURN (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), 1 DAY AFTER STARTING MIDOL HEAT VIBES 3CT. MIDOL HEAT VIBES 3CT WAS WITHDRAWN. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE SITE BURN HAD NOT RESOLVED. THE REPORTER CONSIDERED MEDICAL DEVICE SITE BURN TO BE RELATED TO MIDOL HEAT VIBES 3CT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 1-FEB-2023: UPON INTERNAL REVIEW, THIS CASE WAS FOUND TO BE DUPLICATE OF CASE (B)(4), THIS CASE WAS RETAINED AND THE CASE WAS CONVERTED TO STUDY CASE. ALL DOCUMENTS TRANSFERRED. A TECHNICAL INVESTIGATION WAS CONDUCT, 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.

    Description of Event or Problem · 0

    BAYER CASE NUMBER: (B)(4). THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF THERMAL BURN ("IT BURNT MY STOMACH") IN A 45 YEAR-OLD FEMALE PATIENT WHO RECEIVED MIDOL HEAT VIBES MEDICATED PLASTER (LOT NO. BU22104) FOR PAIN. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. FROM (B)(6) 2023 THE PATIENT RECEIVED MIDOL HEAT VIBES 2 PATCHES. ON (B)(6) 2023, ONE DAY AFTER MIDOL HEAT VIBES INITIATION AND ON THE DAY OF ITS MOST RECENT USE, SHE EXPERIENCED THERMAL BURN (SERIOUSNESS CRITERION MEDICALLY IMPORTANT). MIDOL HEAT VIBES WAS WITHDRAWN. AT THE TIME OF THE REPORT, THE EVENT HAD NOT RESOLVED. THE REPORTER CONSIDERED THERMAL BURN TO BE RELATED TO MIDOL HEAT VIBES ADMINISTRATION. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 27-JAN-2023: INITIAL + FOLLOW UP PROCESS TOGETHER. A TECHNICAL INVESTIGATION WAS CONDUCT, 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.

    Description of Event or Problem · 0

    BAYER CASE NUMBER: (B)(4). THIS 45-YEAR-OLD FEMALE PATIENT WAS IDENTIFIED DURING A MARKET RESEARCH PROGRAM. ADDITIONAL INFORMATION WAS RECEIVED THROUGH SOCIAL MEDIA. THE PATIENT WAS GIVEN MIDOL HEAT VIBES 3CT (LOT NO. BU22104) FOR PAIN. THE CASE DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE SITE BURN ("IT BURNT MY STOMACH"). THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. FROM 17-JAN-2023 TO 18-JAN-2023 THE PATIENT RECEIVED MIDOL HEAT VIBES 3CT 2 PATCHES. ON 18-JAN-2023, ONE DAY AFTER MIDOL HEAT VIBES 3CT INITIATION AND ON THE DAY OF ITS MOST RECENT USE, SHE EXPERIENCED MEDICAL DEVICE SITE BURN (SERIOUSNESS CRITERION MEDICALLY IMPORTANT). MIDOL HEAT VIBES 3CT WAS WITHDRAWN. AT THE TIME OF THE REPORT, THE EVENT HAD NOT RESOLVED. THE REPORTER CONSIDERED MEDICAL DEVICE SITE BURN TO BE RELATED TO MIDOL HEAT VIBES 3CT ADMINISTRATION. QUALITY-SAFETY EVALUATION OF PTC: FOR MIDOL HEAT VIBES 3CT: BASED ON TECHNICAL INVESTIGATION, NO DEVIATIONS OR NONCONFORMANCES WERE NOTED DURING THE REVIEW OF THE BATCH RECORDS. ALL IN-PROCESS INSPECTIONS WERE COMPLETE AND ACCEPTABLE. PRODUCT MADE MET THE MANUFACTURING REQUIREMENT AND FINAL TESTING OF THE PRODUCT MET THE RELEASE SPECIFICATION. THE TEMPERATURE OF THE RETAIN SAMPLE AFTER ACTIVATION WAS WITHIN THE SPECIFIED RANGE (50-60C). BASED ON THE RESULTS, THE INVESTIGATION MET ALL THE REQUIREMENTS. NO FURTHER ACTION IS WARRANTED AT THIS TIME. QA CONTINUES TO MONITOR THIS PRODUCT AND COMPLAINT TYPE AS PART OF THE COMPLAINT TREND REVIEW PROCESS. NO COMPLAINT SAMPLE WAS RECEIVED FOR INVESTIGATION AT 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 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: 08-AUG-2023: QUALITY-SAFETY EVALUATION OF PTC. UNCONFIRMED QUALITY DEFECT. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851168 MIDOL HEAT VIBES PACK, HOT OR COLD, DISPOSABLE IMD WOOSHIN LABOTTACH CO. LTD. BU22104

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Other