BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIDOL HEAT VIBES

    MDR report key: 15155607 · Received August 3, 2022

    Report

    Report Number
    3000206585-2022-00002
    Event Type
    Injury
    Date Received
    August 3, 2022
    Date of Event
    July 4, 2022
    Report Date
    October 10, 2022
    Manufacturer
    WOOSHIN LABOTTACH CO., LTD.
    Product Code
    IMD
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TN, 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 AND DESCRIBES THE OCCURRENCE OF BURNS SECOND DEGREE ('BURNED MY STOMACH / LEFT SECOND DEGREE BURNS ON ME') IN A 31-YEAR-OLD FEMALE PATIENT WHO RECEIVED MIDOL HEAT VIBES MEDICATED PLASTER (BATCH NO. BU21004) FOR PAIN. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON AN UNKNOWN DATE, THE PATIENT STARTED MIDOL HEAT VIBES. ON (B)(6) 2022, THE PATIENT EXPERIENCED BURNS SECOND DEGREE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND EXPERIENCED MEDICAL DEVICE SITE PAIN ("PAIN FROM THE BURNS"), 1 DAY AFTER STARTING MIDOL HEAT VIBES. AT THE TIME OF THE REPORT, THE BURNS SECOND DEGREE AND MEDICAL DEVICE SITE PAIN HAD NOT RESOLVED. THE REPORTER CONSIDERED BURNS SECOND DEGREE AND MEDICAL DEVICE SITE PAIN TO BE RELATED TO MIDOL HEAT VIBES. THE REPORTER COMMENTED: THEY LEFT SECOND DEGREE BURNS ON ME AND I DIDNT PLACE THEM DIRECTLY ON MY SKIN. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2022: CASE (B)(4) WAS DELETED FROM BAYER'S DATABASE AS IT WAS A FOLLOW-UP FOR THIS CASE. FOLLOW-UP: THE EVENT "THERMAL BURN" WAS UPDATED TO "SECOND DEGREE BURN". ON (B)(6) 2022: NO NEW INFORMATION WAS RECEIVED. ON (B)(6) 2022: FOLLOW UP PROCESSED TOGETHER. ON (B)(6) 2022: FOLLOW UP PROCESSED TOGETHER. ON (B)(6) 2022: FOLLOW UP PROCESSED TOGETHER. ON (B)(6) 2022: DATE OF BIRTH OF PATIENT WAS ADDED; PRODUCT INDICATION WAS ADDED. ON (B)(6) 2022: FOLLOW UP PROCESSED TOGETHER. ON (B)(6) 2022: FOLLOW UP PROCESSED TOGETHER. AMENDMENT: THE REPORT WAS ALSO AMENDED FOR THE FOLLOWING REASON: UPON AN INTERNAL REVIEW, CASE UPGRADE TO SERIOUS-INCIDENT. IMDRF CODES UPDATED. 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 BURNS SECOND DEGREE ("BURNED MY STOMACH / LEFT SECOND DEGREE BURNS ON ME") IN A 31 YEAR-OLD FEMALE PATIENT WHO RECEIVED MIDOL HEAT VIBES MEDICATED PLASTER (LOT NO. BU21004) FOR PAIN. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. FROM (B)(6) 2022 THE PATIENT RECEIVED MIDOL HEAT VIBES AT AN UNSPECIFIED DOSE AND FREQUENCY. ON (B)(6) 2022, THE DAY OF MIDOL HEAT VIBES INITIATION, SHE EXPERIENCED BURNS SECOND DEGREE (SERIOUSNESS CRITERION MEDICALLY IMPORTANT) AND MEDICAL DEVICE SITE PAIN ("PAIN FROM THE BURNS"). AT THE TIME OF THE REPORT, NONE OF THE EVENTS HAD RESOLVED. THE REPORTER CONSIDERED BURNS SECOND DEGREE AND MEDICAL DEVICE SITE PAIN TO BE RELATED TO MIDOL HEAT VIBES ADMINISTRATION. THE REPORTER COMMENTED: THEY LEFT SECOND DEGREE BURNS ON ME AND I DIDNT PLACE THEM DIRECTLY ON MY SKIN. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 26-SEP-2022: ALL REQUIRED ATTEMPT WERE COMPLETED BY COMPANY, UPDATE TO INITIAL REPORT WAS TICKED IN DEVICE TAB. 30-SEP-2022: FDA CODE SYNCHRONIZATION. 07-OCT-2022: FDA CODES SYNCHRONIZATION. 10-OCT-2022: FDA CODE SYNCHRONIZATION. 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. PTC INVESTIGATION RESULT: NO COMPLAINT SAMPLE WAS RECEIVED FOR INVESTIGATION BY RESPONSIBLE QUALITY UNIT (RQU). THE INVESTIGATION OF BATCH RECORDS AND RETAINED SAMPLE WAS CONDUCTED AND THE OUTCOME RESULTED IN AN UNCONFIRMED QUALITY DEFECT.

    Description of Event or Problem · 0

    BAYER CASE NUMBER: (B)(4). THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF BURNS SECOND DEGREE ('BURNED MY STOMACH / LEFT SECOND DEGREE BURNS ON ME') IN A 31-YEAR-OLD FEMALE PATIENT WHO RECEIVED MIDOL HEAT VIBES MEDICATED PLASTER (BATCH NO. BU21004) FOR PAIN. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. (B)(6) 2022, THE PATIENT RECEIVED MIDOL HEAT VIBES AT AN UNSPECIFIED DOSE AND FREQUENCY. ON (B)(6) 2022, THE PATIENT EXPERIENCED BURNS SECOND DEGREE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND MEDICAL DEVICE SITE PAIN ("PAIN FROM THE BURNS"). AT THE TIME OF THE REPORT, THE BURNS SECOND DEGREE AND MEDICAL DEVICE SITE PAIN HAD NOT RESOLVED. THE REPORTER CONSIDERED BURNS SECOND DEGREE AND MEDICAL DEVICE SITE PAIN TO BE RELATED TO MIDOL HEAT VIBES. THE REPORTER COMMENTED: THEY LEFT SECOND DEGREE BURNS ON ME AND I DIDNT PLACE THEM DIRECTLY ON MY SKIN MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 22-AUG-2022: ALL REQUIRED ATTEMPT WERE COMPLETED BY COMPANY. UPDATE TO INITIAL WAS TICKED. ON 22-AUG-2022: PRODUCT START AND STOP DATE UPDATED. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1583422 MIDOL HEAT VIBES PACK, HOT OR COLD, DISPOSABLE IMD WOOSHIN LABOTTACH CO., LTD. BU21004

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Female Other