MIDOL HEAT VIBES
Report
- Report Number
- 3000206585-2023-00008
- Event Type
- Injury
- Date Received
- September 29, 2023
- Date of Event
- September 12, 2023
- Report Date
- October 31, 2023
- Manufacturer
- WOOSHIN LABOTTACH CO., LTD.
- Product Code
- IMD
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- NC, 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 ("THIS PATCH BURNED MY SKIN THROUGH MY PANTIES I HAD IT OVER. I HAVE A BURN ON MY STOMACH") IN A 34 YEAR-OLD FEMALE PATIENT WHO RECEIVED MIDOL HEAT VIBES MEDICATED PLASTER FOR PAIN. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. THE ONLY CONCOMITANT PRODUCT MENTIONED WAS IBUPROFEN. ON (B)(6) 2023 THE PATIENT RECEIVED MIDOL HEAT VIBES AT AN UNSPECIFIED DOSE DAILY. ON (B)(6) 2023, THE DAY OF MIDOL HEAT VIBES INITIATION, SHE EXPERIENCED THERMAL BURN (SERIOUSNESS CRITERION MEDICALLY IMPORTANT). AN UNKNOWN TIME LATER SHE EXPERIENCED DISCOMFORT ("SHE STATED THAT SHE STILL FEEL DISCOMFORT."). MIDOL HEAT VIBES WAS WITHDRAWN. ON (B)(6) 2023, THE THERMAL BURN WAS RESOLVING. THE REPORTER CONSIDERED THERMAL BURN TO BE RELATED TO MIDOL HEAT VIBES ADMINISTRATION. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR MIDOL HEAT VIBES WITH REGARD TO DISCOMFORT. THE FOLLOWING AMENDMENT WAS MADE: UPON BAYER INTERNAL REVIEW :THE EVENT 'THIS PATCH BURNED MY SKIN THROUGH MY PANTIES I HAD IT OVER. I HAVE A BURN ON MY STOMACH'-AS REPORTED TERM' WAS RE-CODED TO MEDDRA LLT "SKIN BURN" AND CASE UPGRADED DUE TO SERIOUSNESS CRITERIA ADDED FOR THIS EVENT. NO NEW FOLLOW-UP INFORMATION WAS RECEIVED FROM THE REPORTER. 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.
BAYER CASE NUMBER: (B)(4). THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF APPLICATION SITE BURN ("THIS PATCH BURNED MY SKIN THROUGH MY PANTIES I HAD IT OVER. I HAVE A BURN ON MY STOMACH") IN A 34 YEAR-OLD FEMALE PATIENT WHO RECEIVED MIDOL HEAT VIBES MEDICATED PLASTER FOR PAIN. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. THE ONLY CONCOMITANT PRODUCT MENTIONED WAS IBUPROFEN. ON (B)(6) 2023 THE PATIENT RECEIVED MIDOL HEAT VIBES AT AN UNSPECIFIED DOSE DAILY. ON (B)(6) 2023, THE DAY OF MIDOL HEAT VIBES INITIATION, SHE EXPERIENCED APPLICATION SITE BURN (SERIOUSNESS CRITERION MEDICALLY IMPORTANT). AN UNKNOWN TIME LATER SHE EXPERIENCED DISCOMFORT ("SHE STATED THAT SHE STILL FEEL DISCOMFORT."). MIDOL HEAT VIBES WAS WITHDRAWN. ON (B)(6) 2023, THE APPLICATION SITE BURN WAS RESOLVING. THE REPORTER CONSIDERED APPLICATION SITE BURN TO BE RELATED TO MIDOL HEAT VIBES ADMINISTRATION. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR MIDOL HEAT VIBES WITH REGARD TO DISCOMFORT. QUALITY-SAFETY EVALUATION OF PTC: FOR MIDOL HEAT VIBES: BASED ON TECHNICAL INVESTIGATION, BECAUSE THE BATCH NUMBER IS UNKNOWN, A BATCH RECORD REVIEW COULD NOT BE PERFORMED. A REVIEW OF PRIOR COMPLAINTS WITH REPORTS OF BURN WERE EITHER FOUND TO BE A RESULT TO OF INCORRECT USAGE OR LACK OF INFORMATION PROVIDED BY THE REPORTER. AN INTERNAL INVESTIGATION WAS PERFORMED ON BATCH NUMBERS REPORTED IN PREVIOUS COMPLAINTS WITH REPORTS OF BURN AND IT WAS DETERMINED THAT THE AVERAGE TEMPERATURE OF THE RETAIN SAMPLES WERE WITH SPECIFIED CRITERIA. BASED ON THE ASSESSMENT OF THE PROVIDED INFORMATION, A ROOT CAUSE CANNOT BE DETERMINED. IT IS IMPORTANT TO NOTE THAT INDIVIDUAL PERCEPTIONS OF THE PRODUCT'S HEAT SENSATIONS CAN VARY WIDELY. FACTORS, SUCH AS PATCH PLACEMENT, SKIN INTERACTIONS, USER ACTIVITY AND CLOTHING TYPE CAN INFLUENCE HOW A CONSUMER PERCEIVES THE PRODUCT. AN IN-DEPTH PTC INVESTIGATION CANNOT BE CONDUCTED BY THE QUALITY UNIT AS NEITHER A BATCH NUMBER NOR SAMPLE WAS PROVIDED. A QUALITY DEFECT COULD NOT BE CONFIRMED. 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: 30-OCT-2023: ALL REQUIRED ATTEMPT WERE COMPLETED BY COMPANY, NO ADDITIONAL INFORMATION WAS ADDED. 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 QUALITY DEFECT COULD NOT BE CONFIRMED. THEREFORE THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP BETWEEN THE REPORTED EVENTS AND A QUALITY DEFECT.
BAYER CASE NUMBER: (B)(4). THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF APPLICATION SITE BURN ("THIS PATCH BURNED MY SKIN THROUGH MY PANTIES I HAD IT OVER. I HAVE A BURN ON MY STOMACH") IN A 34 YEAR-OLD FEMALE PATIENT WHO RECEIVED MIDOL HEAT VIBES MEDICATED PLASTER FOR PAIN. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. THE ONLY CONCOMITANT PRODUCT MENTIONED WAS IBUPROFEN. ON (B)(6) 2023, THE PATIENT RECEIVED MIDOL HEAT VIBES AT AN UNSPECIFIED DOSE DAILY. ON (B)(6) 2023, THE DAY OF MIDOL HEAT VIBES INITIATION, SHE EXPERIENCED APPLICATION SITE BURN (SERIOUSNESS CRITERION MEDICALLY IMPORTANT). AN UNKNOWN TIME LATER SHE EXPERIENCED DISCOMFORT ("SHE STATED THAT SHE STILL FEEL DISCOMFORT"). MIDOL HEAT VIBES WAS WITHDRAWN. ON (B)(6) 2023, THE APPLICATION SITE BURN WAS RESOLVING. THE REPORTER CONSIDERED APPLICATION SITE BURN TO BE RELATED TO MIDOL HEAT VIBES ADMINISTRATION. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR MIDOL HEAT VIBES WITH REGARD TO DISCOMFORT. QUALITY-SAFETY EVALUATION OF PTC: FOR MIDOL HEAT VIBES: BASED ON TECHNICAL INVESTIGATION, BECAUSE THE BATCH NUMBER IS UNKNOWN, A BATCH RECORD REVIEW COULD NOT BE PERFORMED. A REVIEW OF PRIOR COMPLAINTS WITH REPORTS OF BURN WERE EITHER FOUND TO BE A RESULT TO OF INCORRECT USAGE OR LACK OF INFORMATION PROVIDED BY THE REPORTER. AN INTERNAL INVESTIGATION WAS PERFORMED ON BATCH NUMBERS REPORTED IN PREVIOUS COMPLAINTS WITH REPORTS OF BURN AND IT WAS DETERMINED THAT THE AVERAGE TEMPERATURE OF THE RETAIN SAMPLES WERE WITH SPECIFIED CRITERIA. BASED ON THE ASSESSMENT OF THE PROVIDED INFORMATION, A ROOT CAUSE CANNOT BE DETERMINED. IT IS IMPORTANT TO NOTE THAT INDIVIDUAL PERCEPTIONS OF THE PRODUCT'S HEAT SENSATIONS CAN VARY WIDELY. FACTORS, SUCH AS PATCH PLACEMENT, SKIN INTERACTIONS, USER ACTIVITY AND CLOTHING TYPE CAN INFLUENCE HOW A CONSUMER PERCEIVES THE PRODUCT. AN IN-DEPTH PTC INVESTIGATION CANNOT BE CONDUCTED BY THE QUALITY UNIT AS NEITHER A BATCH NUMBER NOR SAMPLE WAS PROVIDED. A QUALITY DEFECT COULD NOT BE CONFIRMED. 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: 09-OCT-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 QUALITY DEFECT COULD NOT BE CONFIRMED. THEREFORE THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP BETWEEN THE REPORTED EVENTS AND A QUALITY DEFECT.
BAYER CASE NUMBER: (B)(4). THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF APPLICATION SITE BURN ("THIS PATCH BURNED MY SKIN THROUGH MY PANTIES I HAD IT OVER. I HAVE A BURN ON MY STOMACH") IN A 34 YEAR-OLD FEMALE PATIENT WHO RECEIVED MIDOL HEAT VIBES MEDICATED PLASTER FOR PAIN. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. THE ONLY CONCOMITANT PRODUCT MENTIONED WAS IBUPROFEN. ON (B)(6) 2023 THE PATIENT RECEIVED MIDOL HEAT VIBES AT AN UNSPECIFIED DOSE DAILY. ON (B)(6) 2023, THE DAY OF MIDOL HEAT VIBES INITIATION, SHE EXPERIENCED APPLICATION SITE BURN (SERIOUSNESS CRITERION MEDICALLY IMPORTANT). AN UNKNOWN TIME LATER SHE EXPERIENCED DISCOMFORT ("SHE STATED THAT SHE STILL FEEL DISCOMFORT"). MIDOL HEAT VIBES WAS WITHDRAWN. ON (B)(6) 2023, THE APPLICATION SITE BURN WAS RESOLVING. THE REPORTER CONSIDERED APPLICATION SITE BURN TO BE RELATED TO MIDOL HEAT VIBES ADMINISTRATION. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR MIDOL HEAT VIBES WITH REGARD TO DISCOMFORT. QUALITY-SAFETY EVALUATION OF PTC: FOR MIDOL HEAT VIBES: BASED ON TECHNICAL INVESTIGATION, BECAUSE THE BATCH NUMBER IS UNKNOWN, A BATCH RECORD REVIEW COULD NOT BE PERFORMED. A REVIEW OF PRIOR COMPLAINTS WITH REPORTS OF BURN WERE EITHER FOUND TO BE A RESULT TO OF INCORRECT USAGE OR LACK OF INFORMATION PROVIDED BY THE REPORTER. AN INTERNAL INVESTIGATION WAS PERFORMED ON BATCH NUMBERS REPORTED IN PREVIOUS COMPLAINTS WITH REPORTS OF BURN AND IT WAS DETERMINED THAT THE AVERAGE TEMPERATURE OF THE RETAIN SAMPLES WERE WITH SPECIFIED CRITERIA. BASED ON THE ASSESSMENT OF THE PROVIDED INFORMATION, A ROOT CAUSE CANNOT BE DETERMINED. IT IS IMPORTANT TO NOTE THAT INDIVIDUAL PERCEPTIONS OF THE PRODUCT'S HEAT SENSATIONS CAN VARY WIDELY. FACTORS, SUCH AS PATCH PLACEMENT, SKIN INTERACTIONS, USER ACTIVITY AND CLOTHING TYPE CAN INFLUENCE HOW A CONSUMER PERCEIVES THE PRODUCT. AN IN-DEPTH PTC INVESTIGATION CANNOT BE CONDUCTED BY THE QUALITY UNIT AS NEITHER A BATCH NUMBER NOR SAMPLE WAS PROVIDED. A QUALITY DEFECT COULD NOT BE CONFIRMED. 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: 29-SEP-2023: QUALITY-SAFETY EVALUATION OF PTC, UNCONFIRMED QUALITY DEFECT, ADDED OF GLOBAL PTC NUMBER, TICKED FINAL REPORT, IMDRF CODES ADDED, PQS FIELDS FULFILLED FOR DEVICES. 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 QUALITY DEFECT COULD NOT BE CONFIRMED. THEREFORE THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP BETWEEN THE REPORTED EVENTS AND A QUALITY DEFECT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2287056 | MIDOL HEAT VIBES | PACK, HOT OR COLD, DISPOSABLE | IMD | WOOSHIN LABOTTACH CO., LTD. | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | Female | Other | IBUPROFEN| IBUPROFEN| IBUPROFEN| IBUPROFEN |