MIDOL HEAT VIBES
Report
- Report Number
- 3000206585-2023-00006
- Event Type
- Injury
- Date Received
- July 3, 2023
- Date of Event
- June 21, 2023
- Report Date
- September 5, 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 BURNS SECOND DEGREE ("LI WAS BURNED BY THE PRODUCT, LEAVING A NASTY BLISTER TURNING INTO BURN MARK ON MY STOMACH") IN A 33 YEAR-OLD FEMALE PATIENT WHO RECEIVED MIDOL HEAT VIBES MEDICATED PLASTER (LOT NO. BU22184). 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 (B)(6) 2023 SHE EXPERIENCED BURNS SECOND DEGREE (SERIOUSNESS CRITERION MEDICALLY IMPORTANT). IT WAS UNKNOWN WHETHER ANY ACTION WAS TAKEN WITH MIDOL HEAT VIBES. AT THE TIME OF THE REPORT, THE OUTCOME OF THE EVENT WAS UNKNOWN. THE REPORTER CONSIDERED BURNS SECOND DEGREE 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. ALL IN-PROCESS INSPECTIONS WERE COMPLETE AND ACCEPTABLE. PRODUCT MADE MET THE MANUFACTURING REQUIREMENT AND FINAL TESTING OF THE PRODUCT MET THE RELEASE SPECIFICATION. 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. 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-AUG-2023: ALL REQUIRED FOLLOW-UP ATTEMPTS WERE COMPLETED. UPDATE TO INITIAL REPORT WAS TICKED. 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. PTC INVESTIGATION RESULT: BASED ON TECHNICAL INVESTIGATION, NO DEVIATIONS OR NON-CONFORMANCES WERE NOTED DURING THE REVIEW OF THE BATCH RECORDS.
BAYER CASE NUMBER: (B)(4). THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF BURNS SECOND DEGREE ("LI WAS BURNED BY THE PRODUCT, LEAVING A NASTY BLISTER TURNING INTO BURN MARK ON MY STOMACH") IN A PATIENT WHO RECEIVED MIDOL HEAT VIBES MEDICATED PLASTER (LOT NO. BU22184). 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 AN UNKNOWN DATE THE PATIENT EXPERIENCED BURNS SECOND DEGREE (SERIOUSNESS CRITERION MEDICALLY IMPORTANT). IT WAS UNKNOWN WHETHER ANY ACTION WAS TAKEN WITH MIDOL HEAT VIBES. AT THE TIME OF THE REPORT, THE OUTCOME OF THE EVENT WAS UNKNOWN. THE REPORTER CONSIDERED BURNS SECOND DEGREE 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. ALL IN-PROCESS INSPECTIONS WERE COMPLETE AND ACCEPTABLE. PRODUCT MADE MET THE MANUFACTURING REQUIREMENT AND FINAL TESTING OF THE PRODUCT MET THE RELEASE SPECIFICATION. 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. 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: 06-JUL-2023: QUALITY-SAFETY EVALUATION OF PTC : UNCONFIRMED QUALITY DEFECT, NO DEFECT. UPDATE OF GLOBAL PTC NUMBER. 26-JUN-2023: NO NEW INFORMATION RECEIVED. A TECHNICAL INVESTIGATION WAS CONDUCT, 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. PTC INVESTIGATION RESULT: BASED ON TECHNICAL INVESTIGATION, NO DEVIATIONS OR NON-CONFORMANCES WERE NOTED DURING THE REVIEW OF THE BATCH RECORDS.
BAYER CASE NUMBER: (B)(4). THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF BURNS SECOND DEGREE ("LI WAS BURNED BY THE PRODUCT, LEAVING A NASTY BLISTER TURNING INTO BURN MARK ON MY STOMACH") IN A 33 YEAR-OLD FEMALE PATIENT WHO RECEIVED MIDOL HEAT VIBES MEDICATED PLASTER (LOT NO. BU22184). 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 (B)(6) 2023 SHE EXPERIENCED BURNS SECOND DEGREE (SERIOUSNESS CRITERION MEDICALLY IMPORTANT). IT WAS UNKNOWN WHETHER ANY ACTION WAS TAKEN WITH MIDOL HEAT VIBES. AT THE TIME OF THE REPORT, THE OUTCOME OF THE EVENT WAS UNKNOWN. THE REPORTER CONSIDERED BURNS SECOND DEGREE 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. ALL IN-PROCESS INSPECTIONS WERE COMPLETE AND ACCEPTABLE. PRODUCT MADE MET THE MANUFACTURING REQUIREMENT AND FINAL TESTING OF THE PRODUCT MET THE RELEASE SPECIFICATION. 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. 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: 28-AUG-2023: ALL REQUIRED ATTEMPT WERE COMPLETED BY COMPANY. 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. PTC INVESTIGATION RESULT: BASED ON TECHNICAL INVESTIGATION, NO DEVIATIONS OR NON-CONFORMANCES WERE NOTED DURING THE REVIEW OF THE BATCH RECORDS.
BAYER CASE NUMBER: (B)(6). THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF THERMAL BURN ("I WAS BURNED BY THE PRODUCT") AND BURNS SECOND DEGREE ("LEAVING A NASTY BLISTER TURNING INTO BURN MARK ON MY STOMACH") IN A PATIENT WHO RECEIVED MIDOL HEAT VIBES MEDICATED PLASTER (LOT NO. BU22184). 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) AND BURNS SECOND DEGREE (SERIOUSNESS CRITERION MEDICALLY IMPORTANT). 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. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR MIDOL HEAT VIBES WITH REGARD TO THERMAL BURN OR BURNS SECOND DEGREE. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 26-JUN-2023: NO NEW CLINICAL SIGNIFICANT INFORMATION WAS RECEIVED. THERMAL BURN AND BURNS SECOND DEGREE ARE UNLISTED FOR MIDOL HEAT VIBES (NO ACTIVE INGREDIENT). CONSIDERING THE IMPLIED TEMPORAL RELATIONSHIP BOTH EVENTS WERE, CONSERVATIVELY, DEEMED RELATED TO MIDOL HEAT VIBES (NO ACTIVE INGREDIENT). 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 21654 | MIDOL HEAT VIBES | PACK, HOT OR COLD, DISPOSABLE | IMD | WOOSHIN LABOTTACH CO., LTD. | N/A | BU22184 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR | Female | Other |