BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACARE LOWER BACK & HIP

    MDR report key: 18817383 · Received March 1, 2024

    Report

    Report Number
    3007593958-2024-00014
    Event Type
    Injury
    Date Received
    March 1, 2024
    Date of Event
    December 1, 2023
    Report Date
    March 14, 2024
    Manufacturer
    BRIDGES CONSUMER HEALTHCARE
    Product Code
    IMD
    UDI-DI
    00305733010396
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTABLE NEAR INCIDENT IDENTIFIED INVESTIGATION IN PROGRESS.

    Additional Manufacturer Narrative · 0

    THIS INVESTIGATION WAS CONDUCTED FOR AN UNKNOWN BATCH OF LBH PRODUCT. THERE WAS LIMITED DEVICE SPECIFIC INFORMATION PROVIDED. NO BATCH NUMBER WAS AVAILABLE FOR EVALUATION. WITHOUT A BATCH REFERENCE NUMBER, A MANUFACTURING AND TECHNICAL EVALUATION CANNOT BE COMPLETED FOR THE WRAP INVOLVED IN THIS CASE. A 36-MONTH TREND ANALYSIS HAS BEEN CONDUCTED, THE RECORDS SEARCH RETURNED A TOTAL OF 125 COMPLAINTS FOR LBH PRODUCTS DURING THIS TIME PERIOD. THE SEARCH DESCRIBED IN THIS INVESTIGATION SUMMARY TAKES INTO CONSIDERATION ALL ADVERSE EVENTS. THERE WERE NO COMPLAINTS CONFIRMED TO HAVE A MANUFACTURING RELATED PROCESS ROOT CAUSE FOR A COMPLAINT OF ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION. THERE IS NOT A TREND IDENTIFIED FOR THE SUBCLASS OF ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION FOR THERMACARE LBH PRODUCT. THERE IS NO FURTHER ACTION REQUIRED. CONSIDERING THE CURRENT INFORMATION AVAILABLE FOR THIS COMPLAINT IT IS NOT POSSIBLE TO DETERMINE A ROOT CAUSE. HOWEVER, THERE ARE PRE-IDENTIFIED RISK FACTORS THAT COULD CAUSE BURNS IN THE HAZARD ANALYSIS (RPT-000097160). THERE ARE MITIGATIONS IN PLACE TO PREVENT THESE SITUATIONS SUCH AS IN-PROCESS TESTING, THERMAL TESTING AND VISUAL INSPECTIONS TO ENSURE THE QUALITY AND SAFETY OF THE PRODUCT. THERE ARE ALSO MULTIPLE RISKS THAT ARE OUTSIDE THE CONTROL OF THE SITE. THESE INCLUDE THINGS LIKE AGE, SKIN CONDITION, MEDICAL CONDITIONS, DEVICE USE ERROR AND OFF-LABEL USE. 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, BLISTERS AND SKIN IRRITATIONS. THIS COMPLAINT COMPLIES WITH THE REQUIREMENTS STATED IN INVESTIGATION PROCEDURE (B)(4) PROCESSING CONSUMER COMPLAINTS, EFFECTIVE (B)(6) 2024 AND IT IS RECOMMENDED FOR APPROVAL. THERE ARE PRE-IDENTIFIED RISK FACTORS THAT COULD CAUSE BURNS LISTED IN THE HAZARD ANALYSIS (RPT-000097160). DURING THE INVESTIGATION OF THIS COMPLAINT RPT-000097160 WAS REVIEWED AND NO FURTHER RISK WAS IDENTIFIED. SINCE THIS COMPLAINT IS NOT JUSTIFIED AND THERE IS NO IDENTIFIED DEFECT, THERE IS NO CHANGE NEEDED TO THE RISK DOCUMENTATION AS A RESULT OF THIS INVESTIGATION. BASED ON THE INFORMATION PROVIDED, THE EVENT OF BURN AND WOUND SEPSIS 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 AND THE RELATED WOUND SEPSIS (CONSIDERED AS AN INFECTION LIMITED TO THE SKIN AND NOT GENERALIZED), COULD BE ADVERSE EVENTS OF THIS MEDICAL DEVICE. DECHALLENGE AND RECHALLENGE WERE UNKNOWN. TEMPORAL ASSOCIATION ADVERSE EVENTS-MEDICAL DEVICE IS PLAUSIBLE. BASED ON THE INFORMATION PROVIDED, THE CAUSAL RELATIONSHIP BETWEEN THERMACARE LOWER BACK AND HIP AND THE REPORTED ADVERSE EVENTS WAS CONSIDERED AS POSSIBLE. THIS INVESTIGATION WAS CONDUCTED FOR AN UNKNOWN BATCH NUMBER OF LBH PRODUCT WITH THE SUB CLASS ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION. THERE WAS LIMITED DEVICE SPECIFIC INFORMATION PROVIDED. WITHOUT A VALID BATCH REFERENCE NUMBER, 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 BATCH NUMBER SINCE THE DATE OF MANUFACTURE IS UNKNOWN FOR UNKNOWN BATCH NUMBERS. THERE IS NOT A TREND IDENTIFIED. THERE IS NO FURTHER ACTION REQUIRED. THE MOST PROBABLE ROOT CAUSE CANNOT BE IDENTIFIED.

    Description of Event or Problem · 0

    ANGELINI S.P.A. PROVIDED BRIDGES CONSUMER HEALTHCARE THE CASE INFORMATION ON (B)(6) 2024. ANGELINI S.P.A. RECEIVED THE INFORMATION ON 13-FEB-2024. THE VERBATIM IS AS FOLLOWS: THIS SERIOUS SPONTANEOUS CASE, MANUFACTURER CONTROL NUMBER 2024-033590 IS AN INITIAL REPORT FROM FINLAND RECEIVED ON 13/FEB/2024 FROM A PHARMACIST THROUGH NAVAMEDIC (FINAVAMEDIC-24-004). THIS CASE REPORT CONCERNS A FEMALE PATIENT (AGE: 75-80 YEARS), WHO APPLIED THERMACARE LOWER BACK AND HIP (BATCH NUMBER:UNKNOWN; EXPIRY DATE: UNKNOWN) FOR PAIN IN HIP. CONCOMITANT MEDICATION(S): [UNKNOWN]. MEDICAL HISTORY: UNKNOWN ON (B)(6) 2023, AFTER THERMACARE LOWER BACK AND HIP INITIATION, THE PATIENT EXPERIENCED ABOUT BURN, WOUND INFECTION. SHE HAD USED THE PRODUCT FOR HIP-PAIN (NOT BACK-PAIN). SKIN WAS FINE (NOT DAMAGED) BEFORE USE. THE PHARMACIST TOLD US THAT THE PATIENT HAD NO STRANGE CONCOMITANT MEDICINAL PRODUCTS. PATIENT HAD TO SEEK HOSPITAL CARE DUE TO BURN INJURY OF THE SKIN. THE PHYSICIAN DIAGNOSED HER WITH SEPSIS. THE LADY IS ALREADY FEELING BETTER. OUTCOME: BURN : RECOVERING/ RESOLVING, WOUND INFECTION : RECOVERING/ RESOLVING THE ACTION TAKEN IN RESPONSE TO THE EVENTS FOR THERMACARE LOWER BACK AND HIP WAS UNKNOWN. ANGELINI MEDICAL ASSESSMENT: THE PI OF THERMACARE LOWER BACK AND HIP MENTIONS THAT BURN AND THE RELATED WOUND INFECTION COULD BE ADVERSE EVENTS OF THIS MEDICAL DEVICE. DECHALLENGE AND RECHALLENGE WERE UNKNOWN. TEMPORAL ASSOCIATION ADVERSE EVENTS-MEDICAL DEVICE IS PLAUSIBLE. BASED ON THE INFORMATION PROVIDED, THE CAUSAL RELATIONSHIP BETWEEN THERMACARE LOWER BACK AND HIP AND THE REPORTED ADVERSE EVENTS WAS CONSIDERED AS POSSIBLE. THE OVERALL ASSESSMENT FOR THIS CASE IS SERIOUS/LABELED/POSSIBLE THE ANTICIPATED DATE OF THE NEXT REPORT IS (B)(6) 2024.

    Description of Event or Problem · 0

    ANGELINI S.P.A. PROVIDED BRIDGES CONSUMER HEALTHCARE THE FOLLOWING UPDATED INFORMATION ON 13-MAR-2024. ANGELINI S.P.A. RECEIVED THE INFORMATION ON 28-FEB-2024. FOLLOW UP RECEIVED ON 28/02/2024 FROM NAVAMEDIC AND INVESTIGATION REPORT RECEIVED FROM QA DEPARTMENT ON 01/03/2024. ALL THE INFORMATION WERE MERGED TOGETHER. COMPLAINT NUMBER (B)(4). THE REPORTER STATED THAT THE PATIENT WAS HOSPITALIZED AND THE WOUND SEPSI EVENT WAS RESOLVED. OUTCOME: BURN: RECOVERING/ RESOLVING, WOUND SEPSIS: RECOVERED/RESOLVED. ANGELINI MEDICAL ASSESSMENT: THE INFORMATION PROVIDED IN THIS FOLLOW UP DOES NOT CHANGE THE PREVIOUS ASSESSMENT. WOUND SEPSIS WAS ADDED AS EVENT, EVEN IF IT WAS CONSIDERED AS AN INFECTION LIMITED TO THE SKIN AND NOT GENERALIZED SINCE NO SIGNS OF PRESENCE OF PATHOGENIC MICROORGANISMS IN THE BLOOD STREAM CAUSING A RAPIDLY PROGRESSING SYSTEMIC REACTION THAT MAY LEAD TO SHOCK HAVE BEEN DESCRIBED. THE OVERALL ASSESSMENT FOR THIS CASE IS SERIOUS/LABELED/POSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2001141 THERMACARE LOWER BACK & HIP HOT OR COLD DISPOSABLE PACK. IMD BRIDGES CONSUMER HEALTHCARE 00305733010396

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention