THERMACARE LOWER BACK AND HIP
Report
- Report Number
- 3007593958-2023-00004
- Event Type
- Injury
- Date Received
- January 12, 2023
- Report Date
- April 7, 2023
- Manufacturer
- ANGELINI
- Product Code
- IMD
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- 003
Narratives
REPORTABLE NEAR INCIDENT IDENTIFIED. INVESTIGATION IN PROGRESS. THE ANTICIPATED DATE OF THE NEXT REPORT IS 16-FEB-2023. ON 06-FEB-2023, ANGELINI S.P.A. PROVIDED (B)(6) HEALTHCARE WITH ADDITIONAL INFORMATION. ANGELINI S.P.A. RECEIVED THE INFORMATION ON 30-JAN-2023. THE VERBATIM OF THE INFORMATION FOLLOWS: FOLLOW UP RECEIVED ON 30-JAN-2023 FROM QA DEPARMENT, COMPLAINT NUMBER (B)(4), BATCH CODE UNKNOWN. THE BATCH NUMBER OF THE PRODUCT HAS BEEN REMOVED. BATCH NUMBER INFORMATION WAS REQUESTED BECAUSE THE BATCH PROVIDED WAS INVALID,BUT THE CUSTOMER DOESN'T HAVE THE PACK ANYMORE AND SHE DIDN'T TAKE ANY PICTURES, SO SHE COULDN'T SAY THE BATCH NUMBER. THIS INVESTIGATION WAS CONDUCTED FOR AN UNKNOWN LOT NUMBER OF LOWER BACK/HIP (LBH) 8-HOUR PRODUCT WITH THE SUB CLASS ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION. THERE WAS LIMITED DEVICE SPECIFIC INFORMATION PROVIDED. WITHOUT A BATCH REFERENCE NUMBER, A MANUFACTURING AND TECHNICAL EVALUATION CAN NOT BE COMPLETED FOR THE WRAP INVOLVED IN THIS CASE. PER TRN-000096313, COMPLAINT TRENDING GUIDELINE, EFFECTIVE DATE: 29-JUL-2022, THE COMPLAINT WAS EVALUATED TO IDENTIFY ANY POTENTIAL TRENDS. A 36-MONTH TREND ANALYSIS WILL BE CONDUCTED FOR COMPLAINTS WITH AN UNKNOWN LOT NUMBER SINCE THE DATE OF MANUFACTURE IS NOT KNOWN FOR UNKNOWN LOT NUMBERS.THE FOLLOWING COMPLAINT INTAKE, TRIAGE, AND INVESTIGATION (CITI) CUSTOMIZABLE SEARCH AND TRACKWISE DIGITAL (TWD) COMPLAINTS SEARCH WERE PERFORMED: CITI SCOPE: DATE CONTACTED: 12/28/2019 THROUGH 03/14/2021 MANUFACTURING SITE: PFIZER ALBANY /COMPLAINT CLASS: EXTERNAL CAUSE INVESTIGATION / COMPLAINT SUB CLASS: ADVERSE EVENT SAFETY REQUESTED FOR INVESTIGATION. TWD SCOPE: DATE CONTACTED: 03/15/2021 THROUGH 12/28/2022 MANUFACTURING SITE: ANGELINI ALBANY / COMPLAINT CLASS: UNDESIRABLE SIDE EFFECT/ COMPLAINT SUB CLASS: ADVERSE EVENT SAFETY REQUESTED FOR INVESTIGATION. THE CITI CUSTOMIZABLE AND TWD SEARCH RETURNED A TOTAL OF 97 COMPLAINTS FOR LOWER BACK/HIP (LBH) PRODUCTS DURING THIS PERIOD FOR THE CLASS/SUBCLASS. NONE OF THE COMPLAINTS WERE CONFIRMED TO HAVE A MANUFACTURING PROCESS ROOT CAUSE FOR A COMPLAINT OF ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION. BASED ON THIS CUSTOMIZABLE CITI AND TWD SEARCH, A TREND DOES NOT EXIST FOR THE SUBCLASS ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION FOR LBH 8HR PRODUCTS. REFER TO THE 36-MONTH TRENDING CHART ATTACHMENT UNKNOWN LBH ADVERSE EVENT 12-28-2019 TO 12-28-2022. NO FURTHER ACTION IS REQUIRED BASED ON THE INFORMATION PROVIDED, THE EVENT BURN AS DESCRIBED IN THIS CASE IS CONSIDERED SERIOUS BODILY INJURY POTENTIALLY REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT DAMAGE OR IMPAIRMENT OF BODY STRUCTURE, ASSESSED AS ASSOCIATED WITH THE USE OF THE DEVICE. THE PI OF THERMACARE LOWER BACK AND HIP MENTIONS THAT BURN COULD BE AN ADVERSE EVENT OF THIS MEDICAL DEVICE. DECHALLENGE AND RECHALLENGE WERE UNKNOWN. TEMPORAL ASSOCIATION ADVERSE EVENT-MEDICAL DEVICE IS PLAUSIBLE. BASED ON THE INFORMATION PROVIDED THE CAUSAL RELATIONSHIP BETWEEN THERMACARE LOWER BACK AND HIP AND EVENT IS CONSIDERED AS POSSIBLE. THE BATCH NUMBER OF THE PRODUCT HAS BEEN REMOVED. BATCH NUMBER INFORMATION WAS REQUESTED BECAUSE THE BATCH PROVIDED IN THE INITIAL WAS INVALID. THE INVESTIGATION WAS CONDUCTED FOR AN UNSPECIFIED THERMACARE PRODUCT. THERE WAS LIMITED DEVICE SPECIFIC INFORMATION PROVIDED. NO PRODUCT TYPE, BATCH NUMBER OR RETURN SAMPLE WAS AVAILABLE FOR EVALUATION. WITHOUT A BATCH REFERENCE NUMBER AND/OR RETURN SAMPLE, A MANUFACTURING AND TECHNICAL EVALUATION CANNOT BE COMPLETED FOR THE WRAP INVOLVED IN THIS CASE. THE COMPLAINT WAS EVALUATED TO IDENTIFY ANY POTENTIAL TRENDS. A 36-MONTH TREND ANALYSIS WILL BE CONDUCTED FOR COMPLAINTS WITH AN UNKNOWN LOT NUMBER SINCE THE DATE OF MANUFACTURE IS NOT KNOWN FOR UNKNOWN LOT NUMBERS. THE TRACKWISE DIGITAL (TWD) COMPLAINT SEARCH WAS PERFORMED FOR PRODUCT DESCRIPTION LISTED AS THERMACARE NON SPECIFIC PRODUCT DESCRIPTION. NO SPECIFIC PRODUCT DESCRIPTION WAS PROVIDED AT INTAKE. THE TWD SEARCH RETURNED A TOTAL OF 16 COMPLAINTS FOR THE NON SPECIFIC THERMACARE PRODUCTS. THERE WERE NO COMPLAINTS CONFIRMED TO HAVE A MANUFACTURING RELATED PROCESS ROOT CAUSE FOR A COMPLAINT OF ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION. BASED ON THIS TWD SEARCH, THE DATA DID NOT SHOW AN INCREASE OVER TIME. THERE IS NOT A TREND IDENTIFIED FOR THE SUBCLASS OF ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION FOR THERMACARE NON SPECIFIC PRODUCT. THERE IS NO FURTHER ACTION REQUIRED.
REPORTABLE NEAR INCIDENT IDENTIFIED. INVESTIGATION IN PROGRESS. THE ANTICIPATED DATE OF THE NEXT REPORT IS (B)(6) 2023.
ANGELINI S.P.A. RECEIVED ADDITIONAL INFORMATION ON 03-APR-2023. ANGELINI S.P.A. PROVIDED BRIDGES CONSUMER HEALTHCARE THE INFORMATION ON 05-APR-2023. FOLLOW UP RECEIVED ON 03-APR-2023 FROM QA DEPARTMENT, COMPLAINT NUMBER (B)(4), BATCH CODE UNKNOWN: THIS INVESTIGATION WAS CONDUCTED FOR AN UNKNOWN LOT NUMBER OF LOWER BACK/HIP (LBH) 8-HOUR PRODUCT WITH THE SUB CLASS ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION. THERE WAS LIMITED DEVICE SPECIFIC INFORMATION PROVIDED. WITHOUT A BATCH REFERENCE NUMBER, A MANUFACTURING EVALUATION CANNOT BE COMPLETED FOR THE WRAP INVOLVED IN THIS CASE. NO PRODUCT QUALITY-RELATED TREND WAS IDENTIFIED FOR THE SUBCLASS ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION. THE MOST PROBABLE ROOT CAUSE IS LINKED TO INTENTIONAL DEVICE MISUSE. CARE SHOULD BE TAKEN WHEN USING THE DEVICE, FOLLOWING ALL SAFETY AND USE INFORMATION AS PROVIDED WITH THE WRAP TO AVOID UNDESIRABLE SIDE EFFECTS. THE MANUFACTURING OPERATIONS EMPLOY QUALITY CONTROL PROCEDURES, INCLUDING PROCESS TESTING, THERMAL TESTING, AND VISUAL INSPECTION, TO ENSURE THE QUALITY OF THE PACKAGED PRODUCT. WITHOUT BATCH INFORMATION AVAILABLE, IT IS IMPOSSIBLE TO ASSIGN A ROOT CAUSE FOR THIS COMPLAINT. TO IDENTIFY A MOST PROBABLE ROOT CAUSE, THERE ARE PRE-IDENTIFIED RISK FACTORS THAT COULD CAUSE A BURN LISTED IN THE HAZARD ANALYSIS (RPT-000097160). THERE ARE SEVERAL MATERIAL AND PRODUCT DEFECT RISK FACTORS THAT ARE IDENTIFIED AND MITIGATED TO REDUCE THE RISK OF THESE DEFECTS REACHING OUR CUSTOMERS. WHILE THE SITE TAKES EVERY PRECAUTION TO IDENTIFY POTENTIAL RISK, THERE ARE MULTIPLE RISKS THAT ARE OUTSIDE THE CONTROL OF THE SITE. THESE INCLUDE ASPECTS LIKE SKIN CONDITION, INTENTIONAL DEVICE USE IN UNAPPROVED AGE GROUP AND OTHER MEDICAL CONDITIONS. THE WARNING LABELS ON OUR PRODUCT ARE USED TO ADDRESS THESE RISKS AND RELAY THE APPROPRIATE INSTRUCTIONS FOR USE TO OUR CUSTOMERS TO AVOID BURNS. DATA ANALYSIS WAS PERFORMED TAKING THE PERIOD FROM 12-28-2019 TO 12-28-2022 WITH COMPLAINT SUB CLASS: ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION. SEARCHES RETURNED A TOTAL 97 COMPLAINTS FOR THE THERMACARE LOWER BACK AND HIP PRODUCTS DURING THIS TIME PERIOD FOR THE CLASS/SUBCLASS. OVER TIME FOR 36-MONTHS, THERE IS NOT A TREND IDENTIFIED FOR THE SUBCLASSES OF ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION FOR THE THERMACARE LOWER BACK AND HIP PRODUCTS. THERE IS NO FURTHER ACTION REQUIRED. THE SEARCH DESCRIBED IN THE INVESTIGATION SUMMARY TAKES INTO CONSIDERATION ALL ADVERSE EVENTS. THIS SEARCH WAS NOT SPECIFIC TO BURNS ONLY, THEREFORE IT IS NOT INTENDED TO BE USED FOR DETERMINING SIMILAR INCIDENTS AS PER MIR HELP TEXT OF THE COMMISSION. ACCORDING TO HAZARD ANALYSIS (RPT-000097160), NO NEW RISK WAS IDENTIFIED DURING THE COMPLAINT INVESTIGATION. BASED ON THE HISTORICAL DATA OF THE COMPLAINTS RECEIVED THE RESEARCH WAS PERFORMED FOR THE SUBCLASS ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION FOR LOWER BACK HIP PRODUCTS. THE DATA DID NOT SHOW AN INCREASE OVER TIME FOR 36 MONTHS. ON THE BASIS OF THIS EVALUATION, A TREND DOES NOT EXIST AND THEREFORE, THE RISK ASSESSMENT INCLUDED IN THE TECHNICAL FILE IS NOT IMPACTED. BASED ON THE INFORMATION PROVIDED, THE EVENTS OF BURN, BURN BLISTER AND INTENTIONAL DEVICE MISUSE AS DESCRIBED IN THIS CASE ARE CONSIDERED SERIOUS BODILY INJURY POTENTIALLY REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT DAMAGE OR IMPAIRMENT OF BODY STRUCTURE, ASSESSED AS ASSOCIATED WITH THE USE OF THE DEVICE. PI OF THERMACARE LOWER BACK AND HIP MENTIONS THAT BURN AND BURN BLISTER COULD BE ADVERSE EVENTS OF THIS MEDICAL DEVICE, WHEREAS IT DOES NOT MENTION INTENTIONAL DEVICE MISUSE. TEMPORAL ASSOCIATION ADVERSE EVENTS-MEDICAL DEVICE IS PLAUSIBLE. BASED ON THE INFORMATION PROVIDED THE CAUSAL RELATIONSHIP BETWEEN THERMACARE LOWER BACK AND HIP AND INCIDENT IS CONSIDERED AS POSSIBLE. THIS INVESTIGATION WAS CONDUCTED FOR AN UNKNOWN LOT NUMBER OF LOWER BACK/HIP (LBH) 8-HOUR PRODUCT WITH THE SUB CLASS ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION. THERE WAS LIMITED DEVICE SPECIFIC INFORMATION PROVIDED. WITHOUT A BATCH REFERENCE NUMBER, A MANUFACTURING EVALUATION CANNOT BE COMPLETED FOR THE WRAP INVOLVED IN THIS CASE. NO PRODUCT QUALITY-RELATED TREND WAS IDENTIFIED FOR THE SUBCLASS ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION. DATA ANALYSIS WAS PERFORMED TAKING THE PERIOD FROM 12-28-2019 TO 12-28-2022 WITH COMPLAINT SUB CLASS: ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION. SEARCHES RETURNED A TOTAL 97 COMPLAINTS FOR THE THERMACARE LOWER BACK AND HIP PRODUCTS. THERE IS NOT A TREND IDENTIFIED FOR THE SUBCLASSES OF ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION FOR THE THERMACARE LOWER BACK AND HIP PRODUCTS. WITHOUT BATCH INFORMATION AVAILABLE, IT IS IMPOSSIBLE TO ASSIGN A ROOT CAUSE FOR THIS COMPLAINT. THE MOST PROBABLE ROOT CAUSE IS LINKED TO INTENTIONAL DEVICE MISUSE.
ON 10-JAN-2023, ANGELINI S.P.A. PROVIDED (B)(6) HEALTHCARE WITH THE REPORT. ANGELINI S.P.A. RECEIVED THE INFORMATION ON 28-DEC-2022. THE REPORT VERBATIM IS AS FOLLOWS. THIS SERIOUS SPONTANEOUS CASE, MANUFACTURER CONTROL NUMBER 2022-029514 IS AN INITIAL REPORT FROM GERMANY RECEIVED ON 28-DEC-2022 FROM A CONSUMER/OTHER NON HEALTH PROFESSIONAL THROUGH ANGELINI (DE2392). THIS CASE REPORT CONCERNS A FEMALE PATIENT (AGE NOT REPORTED), WHO APPLIED TOPICALLY THERMACARE LBH X 4 PATCHES (BATCH NUMBER TA14975, APPROVAL N.F00573301009W) FOR UNKNOWN INDICATION, ON UNKNOWN DATE. CONCOMITANT MEDICATIONS AND MEDICAL HISTORY NOT REPORTED. ON UNKNOWN DATE, AFTER THERMACARE LBH X 4 PATCHES INITIATION, THE PATIENT DEVELOPED BURN. OUTCOME: BURN : UNKNOWN. THE ACTION TAKEN IN RESPONSE TO THE EVENTS WAS UNKNOWN.
ON (B)(6) 2023, ANGELINI S.P.A. PROVIDED BRIDGES CONSUMER HEALTHCARE WITH THE REPORT. ANGELINI S.P.A. RECEIVED THE INFORMATION ON (B)(6) 2022. THE REPORT VERBATIM IS AS FOLLOWS. THIS SERIOUS SPONTANEOUS CASE, MANUFACTURER CONTROL NUMBER (B)(4) IS AN INITIAL REPORT FROM GERMANY RECEIVED ON (B)(6) 2022 FROM A CONSUMER/OTHER NON HEALTH PROFESSIONAL THROUGH (B)(6) (DE2392). THIS CASE REPORT CONCERNS A FEMALE PATIENT (AGE NOT REPORTED), WHO APPLIED TOPICALLY THERMACARE LBH X 4 PATCHES (BATCH NUMBER TA14975, APPROVAL (B)(6)) FOR UNKNOWN INDICATION, ON UNKNOWN DATE. CONCOMITANT MEDICATIONS AND MEDICAL HISTORY NOT REPORTED. ON UNKNOWN DATE, AFTER THERMACARE LBH X 4 PATCHES INITIATION, THE PATIENT DEVELOPED BURN. OUTCOME: BURN : UNKNOWN. THE ACTION TAKEN IN RESPONSE TO THE EVENTS WAS UNKNOWN.
ON 23-FEB-2023 AND 08-MAR-2023 ADDITIONAL INFORMATION WAS RECEIVED FROM A CONSUMER VIA ANGELINI S.P.A AND PROVIDED TO BRIDGES CONSUMER HEALTHCARE ON 05-APR-2023. THE REPORT VERBATIM IS AS FOLLOWS. THIS SERIOUS SPONTANEOUS CASE, MANUFACTURER CONTROL NUMBER 2022-029514 IS AN INITIAL REPORT FROM GERMANY RECEIVED ON 28-DEC-2022 FROM A CONSUMER/OTHER NON-HEALTH PROFESSIONAL THROUGH ANGELINI (DE2392). THIS CASE REPORT CONCERNS A FEMALE PATIENT (AGE NOT REPORTED), WHO APPLIED TOPICALLY THERMACARE LBH X 4 PATCHES (BATCH NUMBER TA14975, APPROVAL N.F00573301009W) FOR UNKNOWN INDICATION, ON UNKNOWN DATE. CONCOMITANT MEDICATIONS AND MEDICAL HISTORY NOT REPORTED. ON UNKNOWN DATE, AFTER THERMACARE LBH X 4 PATCHES INITIATION, THE PATIENT DEVELOPED BURN. OUTCOME: BURN: UNKNOWN. THE ACTION TAKEN IN RESPONSE TO THE EVENTS WAS UNKNOWN. ADDITIONAL INFORMATION WAS RECEIVED ON 23-FEB-2023 VIA LETTER FROM THE PATIENT. THE FEMALE PATIENT STATED THAT SHE IS ABOVE 60 YEARS OLD AND USED THE THERMACARE HEAT WRAPS FOR THE BACK AND LUMBAR REGION. SHE HAD ADMINISTERED THE PRODUCT ON THE AFFECTED AREA ACCORDING TO THE PRODUCT INSTRUCTION DURING THE DAY FOR 7 HOURS. ADDITIONAL INFORMATION WAS RECEIVED ON 08-MAR-2023 VIA PHONE CALL FROM THE PATIENT. THE FEMALE PATIENT STATED THAT SHE HAD ALREADY USED THERMACARE HEAT WRAPS SEVERAL TIMES AND NEVER HAD ISSUES. REGARDING THE INCIDENT, SHE STATED THAT SHE HAD ADMINISTERED THE PRODUCT DIRECTLY ON THE SKIN FOR 6 TO 7 HOURS (INTENTIONAL DEVICE MISUSE). ABOUT 4 DAYS AFTER REMOVING THE PRODUCT SHE HAD NOTICED SOME SKIN REACTION ON HER BACK AND CONSULTED HER DOCTOR. ACCORDING TO THE DOCTOR, THE PATIENT SUFFERED FROM A BLISTER DUE TO BURNING (BURN BLISTER). THE PATIENT HAS TREATED THE BLISTER WITH OINTMENT AND A BAND-AID AND IS NOW FEELING WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1392629 | THERMACARE LOWER BACK AND HIP | HOT OR COLD DISPOSABLE PACK | IMD | ANGELINI | TA14975 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention |