BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIDOL HEAT VIBES

    MDR report key: 25253300 · Received May 22, 2026

    Report

    Report Number
    3000206585-2026-00008
    Event Type
    Injury
    Date Received
    May 22, 2026
    Date of Event
    May 18, 2026
    Report Date
    May 26, 2026
    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). END UP WITH A THIRD-DEGREE BURN [BURNS THIRD DEGREE]. PAIN [PAIN]. ABDOMEN. BLISTERS [BURN BLISTER]. CASE NARRATIVE: THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF BURNS THIRD DEGREE ("END UP WITH A THIRD-DEGREE BURN"), PAIN ("PAIN") AND BURNS SECOND DEGREE ("ABDOMEN. BLISTERS") IN A 33 YEAR-OLD FEMALE PATIENT WHO RECEIVED MIDOL HEAT VIBES MEDICATED PLASTER (LOT NO. BU25075) FOR PAIN. AS CONCURRENT CONDITION THE REPORT MENTIONED POLYCYSTIC OVARIAN SYNDROME. FROM (B)(6) 2026 THE PATIENT RECEIVED MIDOL HEAT VIBES (TOPICAL) 1 DF DAILY. ON (B)(6) 2026, ONE DAY AFTER MIDOL HEAT VIBES INITIATION AND ON THE DAY OF ITS MOST RECENT USE, SHE EXPERIENCED BURNS THIRD DEGREE (SERIOUSNESS CRITERION MEDICALLY IMPORTANT), PAIN (SERIOUSNESS CRITERION MEDICALLY IMPORTANT) AND BURNS SECOND DEGREE (SERIOUSNESS CRITERION MEDICALLY IMPORTANT). THE PATIENT WAS TREATED WITH ANTIBIOTICS (UNKNOWN) AND OTHER THERAPEUTIC PRODUCTS (UNKNOWN). MIDOL HEAT VIBES WAS WITHDRAWN. AT THE TIME OF THE REPORT, NONE OF THE EVENTS HAD RESOLVED. THE REPORTER CONSIDERED BURNS SECOND DEGREE, BURNS THIRD DEGREE AND PAIN TO BE RELATED TO MIDOL HEAT VIBES ADMINISTRATION. THE REPORTER COMMENTED: FIRST TIME USING THESE ONES AND END UP WITH A THIRD-DEGREE BURN. IT WAS THE SECOND PATCH THAT BURNED HER AND IT WAS A DIFFERENT SIDE OF HER BODY. THE FIRST NIGHT SHE USED IT ON THE ONE SIDE. SHE USED ONE ON THE ON SUNDAY THAT WAS FINE AND USED ONE ON MONDAY ON THE OPPOSITE SIDE OF HER BODY AND THAT WAS WHEN SHE RECEIVED THE BURN. SHE WAS ON AN ANTIBIOTIC AND A CREAM DUE TO THE BURN. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 19-MAY-2026: OUTCOME OF EVENTS UPDATED TO NOT RECOVERED. AMENDMENT: EVEN PAIN ADDED. TREATMENT PRODUCT ADDED. NARRATIVE WAS UPDATED. 22-MAY-2026: NO NEW INFORMATION WAS RECEIVED. CASE COMMENTS: A TECHNICAL INVESTIGATION WILL BE 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. IN CASE A SAMPLE IS RECEIVED, THE INVESTIGATION MIGHT LEAD TO DESTRUCTION OF THE SAMPLE IF REQUIRED TO PERFORM A PROPER ANALYSIS.

    Description of Event or Problem · 0

    BAYER CASE NUMBER: (B)(4). I END UP WITH A THIRD-DEGREE BURN [BURNS THIRD DEGREE]. ABDOMEN. BLISTERS [BURN BLISTER]. CASE NARRATIVE: THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF BURNS THIRD DEGREE ("I END UP WITH A THIRD-DEGREE BURN") AND BURNS SECOND DEGREE ("ABDOMEN. BLISTERS") IN A 33-YEAR-OLD FEMALE PATIENT WHO RECEIVED MIDOL HEAT VIBES MEDICATED PLASTER (LOT NO. BU25075) FOR PAIN. THE PATIENT HAD A MEDICAL HISTORY OF POLYCYSTIC OVARIAN SYNDROME. FROM (B)(6) 2026 TO (B)(6) 2026 THE PATIENT RECEIVED MIDOL HEAT VIBES (TOPICAL) 1 DF DAILY. ON (B)(6) 2026, ONE DAY AFTER MIDOL HEAT VIBES INITIATION AND ON THE DAY OF ITS MOST RECENT USE, SHE EXPERIENCED BURNS THIRD DEGREE (SERIOUSNESS CRITERION MEDICALLY IMPORTANT) AND BURNS SECOND DEGREE (SERIOUSNESS CRITERION MEDICALLY IMPORTANT). MIDOL HEAT VIBES WAS WITHDRAWN. ON (B)(6) 2026, ALL OF THE EVENTS HAD RESOLVED WITH SEQUELAE. THE REPORTER CONSIDERED BURNS SECOND DEGREE AND BURNS THIRD DEGREE TO BE RELATED TO MIDOL HEAT VIBES ADMINISTRATION. CASE COMMENTS: A TECHNICAL INVESTIGATION WILL BE 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. IN CASE A SAMPLE IS RECEIVED, THE INVESTIGATION MIGHT LEAD TO DESTRUCTION OF THE SAMPLE IF REQUIRED TO PERFORM A PROPER ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611926 MIDOL HEAT VIBES PACK, HOT OR COLD, DISPOSABLE IMD WOOSHIN LABOTTACH, CO, LTD BU25075

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female Other