BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIDOL HEAT VIBES

    MDR report key: 16459568 · Received March 1, 2023

    Report

    Report Number
    3000206585-2023-00003
    Event Type
    Injury
    Date Received
    March 1, 2023
    Report Date
    May 8, 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 PATIENT WAS IDENTIFIED DURING A MARKET RESEARCH PROGRAM. THE PATIENT WAS GIVEN MIDOL HEAT VIBES UNKNOWN. THE CASE DESCRIBES THE OCCURRENCE OF THERMAL BURN ("MY SKIN BURNED WHILE WEARING THESE BUT PLEASE NOTE I DO HAVE VERY FAIR/SENSITIVE SKIN SO I DO TEND TO BURN EASILY."). THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON AN UNKNOWN DATE, THE PATIENT STARTED MIDOL HEAT VIBES UNKNOWN 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 UNKNOWN. 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 UNKNOWN ADMINISTRATION. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: (B)(6) 2023: INI +FU1+FU2 +FU3 +FU4 PROCESS TOGETHER. (B)(6) 2023: INI +FU1+FU2 +FU3 +FU4 PROCESS TOGETHER. (B)(6) 2023: INI +FU1+FU2 +FU3 +FU4 PROCESS TOGETHER. (B)(6) 2023: INI +FU1+FU2 +FU3 +FU4 PROCESS TOGETHER. 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 PATIENT WAS IDENTIFIED DURING A MARKET RESEARCH PROGRAM. THE PATIENT WAS GIVEN MIDOL HEAT VIBES UNKNOWN (LOT NO. UNK). THE CASE DESCRIBES THE OCCURRENCE OF THERMAL BURN ("MY SKIN BURNED WHILE WEARING THESE BUT PLEASE NOTE I DO HAVE VERY FAIR/SENSITIVE SKIN SO I DO TEND TO BURN EASILY."). THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON AN UNKNOWN DATE, THE PATIENT STARTED MIDOL HEAT VIBES UNKNOWN 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 UNKNOWN. 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 UNKNOWN ADMINISTRATION. QUALITY-SAFETY EVALUATION OF PTC: FOR MIDOL HEAT VIBES UNKNOWN: 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: 10-MAR-2023: ADDITION OF QUALITY-SAFETY EVALUATION OF PTC: UNCONFIRMED QUALITY DEFECT, UPDATE OF GLOBAL PTC NUMBER, ADDITION OF IMDRF CODES, FINAL REPORT 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.

    Description of Event or Problem · 0

    BAYER CASE NUMBER: (B)(4). THIS PATIENT WAS IDENTIFIED DURING A MARKET RESEARCH PROGRAM. THE PATIENT WAS GIVEN MIDOL HEAT VIBES UNKNOWN (LOT NO. UNKUNKNOWN). THE CASE DESCRIBES THE OCCURRENCE OF THERMAL BURN ("MY SKIN BURNED WHILE WEARING THESE BUT PLEASE NOTE I DO HAVE VERY FAIR/SENSITIVE SKIN SO I DO TEND TO BURN EASILY."). THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON AN UNKNOWN DATE, THE PATIENT STARTED MIDOL HEAT VIBES UNKNOWN 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 UNKNOWN. 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 UNKNOWN ADMINISTRATION. QUALITY-SAFETY EVALUATION OF PTC: FOR MIDOL HEAT VIBES UNKNOWN: 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: 13-APR-2023: ALL REQUIRED ATTEMPT WERE COMPLETED BY COMPANY, UPDATE TO INITIAL REPORT 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.

    Description of Event or Problem · 0

    BAYER CASE NUMBER: (B)(4) THIS PATIENT WAS IDENTIFIED DURING A MARKET RESEARCH PROGRAM. THE PATIENT WAS GIVEN MIDOL HEAT VIBES UNKNOWN (LOT NO. UNKNOWN). THE CASE DESCRIBES THE OCCURRENCE OF THERMAL BURN ("MY SKIN BURNED WHILE WEARING THESE BUT PLEASE NOTE I DO HAVE VERY FAIR/SENSITIVE SKIN SO I DO TEND TO BURN EASILY."). THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON AN UNKNOWN DATE, THE PATIENT STARTED MIDOL HEAT VIBES UNKNOWN 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 UNKNOWN. 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 UNKNOWN ADMINISTRATION. QUALITY-SAFETY EVALUATION OF PTC: FOR MIDOL HEAT VIBES UNKNOWN: 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: 04-MAY-2023: ALL REQUIRED ATTEMPT WERE COMPLETED BY COMPANY. 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
    921300 MIDOL HEAT VIBES PACK, HOT OR COLD, DISPOSABLE IMD WOOSHIN LABOTTACH CO., LTD. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other