MIDOL HEAT VIBES
Report
- Report Number
- 3000206585-2023-00007
- Event Type
- Injury
- Date Received
- August 29, 2023
- Date of Event
- August 21, 2023
- Report Date
- October 27, 2023
- Manufacturer
- WOOSHIN LABOTTACH CO., LTD.
- Product Code
- IMD
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
BAYER CASE NUMBER: (B)(4). THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF THERMAL BURN ("THE PRODUCT BURNT MY SKIN AND LEFT BLISTERS AND RED PATCHES") AND BURNS SECOND DEGREE ("THE PRODUCT BURNT MY SKIN AND LEFT BLISTERS AND RED PATCHES") IN A 26 YEAR-OLD FEMALE PATIENT WHO RECEIVED MIDOL HEAT VIBES MEDICATED PLASTER (LOT NO. BUC2145) FOR PAIN. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON (B)(6) 2023 THE PATIENT RECEIVED MIDOL HEAT VIBES 1 PATCH. ON (B)(6) 2023, THE DAY OF MIDOL HEAT VIBES INITIATION, SHE EXPERIENCED THERMAL BURN (SERIOUSNESS CRITERION MEDICALLY IMPORTANT), BURNS SECOND DEGREE (SERIOUSNESS CRITERION MEDICALLY IMPORTANT), RASH MACULAR ("THE PRODUCT BURNT MY SKIN AND LEFT BLISTERS AND RED PATCHES") AND PAIN ("SEVERE PAIN AS ONE OF THE BURNS HAD A BLISTER THAT POPPED NOT LONG AFTER I REMOVED THE PAD OFF THE CLOTHING"). MIDOL HEAT VIBES WAS WITHDRAWN. THE REPORTER CONSIDERED BURNS SECOND DEGREE, PAIN, RASH MACULAR AND THERMAL BURN TO BE RELATED TO MIDOL HEAT VIBES ADMINISTRATION. IN THIS CASE A 26-YEAR-OLD WOMAN EXPERIENCED BURNS SECOND DEGREE (LISTED), PAIN (UNLISTED), RASH MACULAR (LISTED) AND THERMAL BURN (LISTED) AFTER USING MIDOL HEAT VIBES MEDICATED PLASTER. AS THIS PRODUCT IS WELL KNOWN HAVING A RISK OF CAUSING BURNS AND IRRITATION ON THE SKIN, COMPANY DEEMS ALL EVENTS RELATED TO THE COMPANY PRODUCT IN AGREEMENT WITH THE REPORTER. 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.
BAYER CASE NUMBER: (B)(4). THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF THERMAL BURN ("THE PRODUCT BURNT MY SKIN AND LEFT BLISTERS AND RED PATCHES") AND BURNS SECOND DEGREE ("THE PRODUCT BURNT MY SKIN AND LEFT BLISTERS AND RED PATCHES") IN A 26 YEAR-OLD FEMALE PATIENT WHO RECEIVED MIDOL HEAT VIBES MEDICATED PLASTER (LOT NO. BU22145) FOR PAIN. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON (B)(6) 2023 THE PATIENT RECEIVED MIDOL HEAT VIBES 1 PATCH. ON (B)(6) 2023, THE DAY OF MIDOL HEAT VIBES INITIATION, SHE EXPERIENCED THERMAL BURN (SERIOUSNESS CRITERION MEDICALLY IMPORTANT), BURNS SECOND DEGREE (SERIOUSNESS CRITERION MEDICALLY IMPORTANT), RASH MACULAR ("THE PRODUCT BURNT MY SKIN AND LEFT BLISTERS AND RED PATCHES") AND PAIN ("SEVERE PAIN AS ONE OF THE BURNS HAD A BLISTER THAT POPPED NOT LONG AFTER I REMOVED THE PAD OFF THE CLOTHING"). MIDOL HEAT VIBES WAS WITHDRAWN. THE REPORTER CONSIDERED BURNS SECOND DEGREE, PAIN, RASH MACULAR AND THERMAL BURN TO BE RELATED TO MIDOL HEAT VIBES ADMINISTRATION. QUALITY-SAFETY EVALUATION OF PTC: FOR MIDOL HEAT VIBES: BASED ON TECHNICAL INVESTIGATION, NO DEVIATIONS OR NON-CONFORMANCES WERE NOTED DURING THE REVIEW OF THE BATCH RECORDS AND OF THE RETAINED SAMPLE. THE TEMPERATURE OF THE RETAIN SAMPLE AFTER ACTIVATION WAS WITHIN THE SPECIFIED RANGE. 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. THEREFORE THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP BETWEEN THE REPORTED MEDICAL EVENTS AND A QUALITY DEFECT. 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: 01-SEP-2023: QUALITY-SAFETY EVALUATION OF PTC.UPDATE OF GLOBAL PTC NUMBER, PDF ATTACHED, TICKED FINAL REPORT, UPDATE OF IMDRF CODES AND APPLICABLE MIR FIELDS, DEVICE LOCATION CHANGED TO PATIENT/USER, UPDATED LOT NUMBER, UNCONFIRMED QUALITY DEFECT. IN THIS CASE A 26-YEAR-OLD WOMAN EXPERIENCED BURNS SECOND DEGREE (LISTED), PAIN (UNLISTED), RASH MACULAR (LISTED) AND THERMAL BURN (LISTED) AFTER USING MIDOL HEAT VIBES MEDICATED PLASTER. AS THIS PRODUCT IS WELL KNOWN HAVING A RISK OF CAUSING BURNS AND IRRITATION ON THE SKIN, COMPANY DEEMS ALL EVENTS RELATED TO THE COMPANY PRODUCT IN AGREEMENT WITH THE REPORTER. 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.
BAYER CASE NUMBER: (B)(4). THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF THERMAL BURN ("THE PRODUCT BURNT MY SKIN AND LEFT BLISTERS AND RED PATCHES") AND BURNS SECOND DEGREE ("THE PRODUCT BURNT MY SKIN AND LEFT BLISTERS AND RED PATCHES") IN A 26 YEAR-OLD FEMALE PATIENT WHO RECEIVED MIDOL HEAT VIBES MEDICATED PLASTER (LOT NO. BU22145) FOR PAIN. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON (B)(6) 2023 THE PATIENT RECEIVED MIDOL HEAT VIBES 1 PATCH. ON (B)(6) 2023, THE DAY OF MIDOL HEAT VIBES INITIATION, SHE EXPERIENCED THERMAL BURN (SERIOUSNESS CRITERION MEDICALLY IMPORTANT), BURNS SECOND DEGREE (SERIOUSNESS CRITERION MEDICALLY IMPORTANT), RASH MACULAR ("THE PRODUCT BURNT MY SKIN AND LEFT BLISTERS AND RED PATCHES") AND PAIN ("SEVERE PAIN AS ONE OF THE BURNS HAD A BLISTER THAT POPPED NOT LONG AFTER I REMOVED THE PAD OFF THE CLOTHING"). MIDOL HEAT VIBES WAS WITHDRAWN. THE REPORTER CONSIDERED BURNS SECOND DEGREE, PAIN, RASH MACULAR AND THERMAL BURN TO BE RELATED TO MIDOL HEAT VIBES ADMINISTRATION. QUALITY-SAFETY EVALUATION OF PTC: FOR MIDOL HEAT VIBES: BASED ON TECHNICAL INVESTIGATION, THE REVIEW OF THE BATCH RECORD INDICATES THERE WERE NO REPORTED INCIDENTS OR DEVIATIONS THAT WOULD LEAD TO THE REPORTED DEFECT. IN-PROCESS TESTING WAS PERFORMED AND WAS WITHIN SPECIFICATIONS. RETAIN SAMPLE WAS REVIEWED. NO ANOMALIES WERE FOUND. THE TEMPERATURE OF THE RETAIN SAMPLE AFTER ACTIVATION WAS WITHIN THE SPECIFIED RANGE. THE COMPLAINT SAMPLE WAS RETURNED. THE AVERAGE TEMPERATURE IS 51.2C , AT THE 8TH HOUR, WHICH LIES WITHIN THE RANGE OF 50-60C. THE PTC INVESTIGATION WAS CONDUCTED AND THE OUTCOME OF THE INVESTIGATION RESULTED IN AN UNCONFIRMED QUALITY DEFECT. 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: 25-OCT-2023: UPDATE OF QUALITY-SAFETY EVALUATION OF PTC: UNCONFIRMED QUALITY DEFECT, GLOBAL PTC NUMBER WAS ADDED. IN THIS CASE A 26-YEAR-OLD WOMAN EXPERIENCED BURNS SECOND DEGREE (LISTED) AND THERMAL BURN (LISTED) AFTER USING MIDOL HEAT VIBES MEDICATED PLASTER. AS THIS PRODUCT IS WELL KNOWN HAVING A RISK OF CAUSING BURNS AND IRRITATION ON THE SKIN, COMPANY DEEMS ALL EVENTS RELATED TO THE COMPANY PRODUCT IN AGREEMENT WITH THE REPORTER. 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 |
|---|---|---|---|---|---|---|---|
| 999743 | MIDOL HEAT VIBES | PACK, HOT OR COLD, DISPOSABLE | IMD | WOOSHIN LABOTTACH CO., LTD. | BU22145 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 26 YR | Female | Other |