BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIDOL HEAT VIBES

    MDR report key: 15128690 · Received July 29, 2022

    Report

    Report Number
    3000206585-2022-00001
    Event Type
    Injury
    Date Received
    July 29, 2022
    Report Date
    September 1, 2022
    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 PATIENT WAS IDENTIFIED DURING A MARKET RESEARCH PROGRAM. THE PATIENT RECEIVED MIDOL HEAT VIBES (BATCH NO. UNK) FOR MENSTRUAL CRAMPS. THE CASE DESCRIBES THE OCCURRENCE OF THERMAL BURN ('SKIN BURNS'), BLISTER ('I NOTICED SOME BLISTERS ON MY SKIN') AND BLISTER RUPTURE ('TWO DAYS LATER THESE BLISTERS BURST'). THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON AN UNKNOWN DATE, THE PATIENT STARTED MIDOL HEAT VIBES. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED THERMAL BURN (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BLISTER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BLISTER RUPTURE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND SKIN LESION INFLAMMATION ("I NOW HAVE THIS INFLAMED WOUND ON MY SKIN."). IT WAS UNKNOWN WHETHER ANY ACTION WAS TAKEN WITH MIDOL HEAT VIBES. AT THE TIME OF THE REPORT, THE THERMAL BURN, BLISTER, BLISTER RUPTURE AND SKIN LESION INFLAMMATION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED BLISTER, BLISTER RUPTURE, SKIN LESION INFLAMMATION AND THERMAL BURN TO BE RELATED TO MIDOL HEAT VIBES. QUALITY-SAFETY EVALUATION OF PTC: A PTC INVESTIGATION CANNOT BE CONDUCTED BY THE QUALITY UNIT AS A BATCH NUMBER OR SAMPLE WAS NOT PROVIDED. A QUALITY DEFECT COULD NOT BE CONFIRMED. 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. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 27-JUL-2022: QUALITY-SAFETY EVALUATION OF PTC. AMENDMENT: THE REPORT WAS ALSO AMENDED FOR THE FOLLOWING REASON: UPON AN INTERNAL REVIEW, THE EVENT "THERMAL BURN" WERE ADDED TO THE CASE. EVENT "RASH VESICULAR " WAS UPDATED TO "BLISTER RUPTURE". CASE UPGRADE TO SERIOUS-INCIDENT. IMDRF CODES UPDATED. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT. PTC INVESTIGATION RESULT: A PTC INVESTIGATION CANNOT BE CONDUCTED BY THE QUALITY UNIT AS A BATCH NUMBER OR SAMPLE WAS NOT PROVIDED. A QUALITY DEFECT COULD NOT BE CONFIRMED.

    Description of Event or Problem · 0

    BAYER CASE NUMBER: (B)(64) THIS PATIENT WAS IDENTIFIED DURING A MARKET RESEARCH PROGRAM. THE PATIENT WAS GIVEN MIDOL HEAT VIBES (LOT NO. UNKUNKNOWN) FOR MENSTRUAL CRAMPS. THE CASE DESCRIBES THE OCCURRENCE OF THERMAL BURN ("SKIN BURNS"), BLISTER ("I NOTICED SOME BLISTERS ON MY SKIN") AND BLISTER RUPTURE ("TWO DAYS LATER THESE BLISTERS BURST"). ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. 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 UNKNOWN DATES THE PATIENT EXPERIENCED THERMAL BURN (SERIOUSNESS CRITERION MEDICALLY IMPORTANT), BLISTER (SERIOUSNESS CRITERION MEDICALLY IMPORTANT), BLISTER RUPTURE (SERIOUSNESS CRITERION MEDICALLY IMPORTANT) AND SKIN LESION INFLAMMATION ("I NOW HAVE THIS INFLAMED WOUND ON MY SKIN."). IT WAS UNKNOWN WHETHER ANY ACTION WAS TAKEN WITH MIDOL HEAT VIBES. AT THE TIME OF THE REPORT, THE OUTCOMES FOR THESE EVENTS WERE UNKNOWN. THE REPORTER CONSIDERED BLISTER, BLISTER RUPTURE, SKIN LESION INFLAMMATION AND THERMAL BURN TO BE RELATED TO MIDOL HEAT VIBES ADMINISTRATION. QUALITY-SAFETY EVALUATION OF PTC: FOR MIDOL HEAT VIBES: A PTC INVESTIGATION CANNOT BE CONDUCTED BY THE QUALITY UNIT AS A BATCH NUMBER OR SAMPLE WAS NOT PROVIDED. A QUALITY DEFECT COULD NOT BE CONFIRMED. 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: 24-AUG-2022: QUALITY-SAFETY EVALUATION OF PTC. ANNEX A UPDATED. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT. PTC INVESTIGATION RESULT: A PTC INVESTIGATION CANNOT BE CONDUCTED BY THE QUALITY UNIT AS A BATCH NUMBER OR SAMPLE WAS NOT PROVIDED. A QUALITY DEFECT COULD NOT BE CONFIRMED.

    Description of Event or Problem · 0

    BAYER CASE NUMBER: (B)(4). THIS PATIENT WAS IDENTIFIED DURING A MARKET RESEARCH PROGRAM. THE PATIENT RECEIVED MIDOL HEAT VIBES (BATCH NO. UNK) FOR MENSTRUAL CRAMPS. THE CASE DESCRIBES THE OCCURRENCE OF THERMAL BURN ('SKIN BURNS'), BLISTER ('I NOTICED SOME BLISTERS ON MY SKIN') AND BLISTER RUPTURE ('TWO DAYS LATER THESE BLISTERS BURST'). THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON AN UNKNOWN DATE, THE PATIENT STARTED MIDOL HEAT VIBES. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED THERMAL BURN (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BLISTER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BLISTER RUPTURE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND SKIN LESION INFLAMMATION ("I NOW HAVE THIS INFLAMED WOUND ON MY SKIN."). IT WAS UNKNOWN WHETHER ANY ACTION WAS TAKEN WITH MIDOL HEAT VIBES. AT THE TIME OF THE REPORT, THE THERMAL BURN, BLISTER, BLISTER RUPTURE AND SKIN LESION INFLAMMATION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED BLISTER, BLISTER RUPTURE, SKIN LESION INFLAMMATION AND THERMAL BURN TO BE RELATED TO MIDOL HEAT VIBES. QUALITY-SAFETY EVALUATION OF PTC: A PTC INVESTIGATION CANNOT BE CONDUCTED BY THE QUALITY UNIT AS A BATCH NUMBER OR SAMPLE WAS NOT PROVIDED. A QUALITY DEFECT COULD NOT BE CONFIRMED. 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. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 30-AUG-2022: ALL REQUIRED ATTEMPT WERE COMPLETED BY COMPANY. UPDATE TO INITIAL WAS TICKED. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT. PTC INVESTIGATION RESULT: A PTC INVESTIGATION CANNOT BE CONDUCTED BY THE QUALITY UNIT AS A BATCH NUMBER OR SAMPLE WAS NOT PROVIDED. A QUALITY DEFECT COULD NOT BE CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1343184 MIDOL HEAT VIBES PACK, HOT OR COLD, DISPOSABLE IMD WOOSHIN LABOTTACH CO., LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other