BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMACARE LOWER BACK & HIP

    MDR report key: 9267106 · Received November 1, 2019

    Report

    Report Number
    1066015-2019-00470
    Event Type
    Malfunction
    Date Received
    November 1, 2019
    Report Date
    October 2, 2019
    Manufacturer
    PFIZER CONSUMER HEALTH CARE
    Product Code
    IMD
    PMA / PMN Number
    K953442
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CONCLUSION: THE ROOT CAUSE CATEGORY IS NON-ASSIGNABLE (COMPLAINT NOT CONFIRMED AS A QUALITY DEFECT). THERE WAS LIMITED DEVICE SPECIFIC INFORMATION PROVIDED, NO 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. THERE IS NOT A PRODUCT QUALITY RELATED TREND IDENTIFIED FOR THE SUBCLASS PRODUCT USE ATTRIBUTES DEFECT NOT CLASSIFIED. THE MANUFACTURING OPERATIONS EMPLOY QUALITY CONTROL PROCEDURES WHICH INCLUDE IN PROCESS TESTING, THERMAL TESTING AND VISUAL INSPECTION, TO ENSURE THE QUALITY OF THE PRODUCT BEING PACKAGED. OTHER TREND ASSMT. & RATIONALE: AN EVALUATION WAS MADE BY SEARCHING FOR POSSIBLE TRENDS FOR THIS SUBCLASS REQUIRING INVESTIGATION BY THE SITE. THE FOLLOWING COMPLAINT INTAKE, TRIAGE AND INVESTIGATION (CITI) SEARCH WAS PERFORMED: SCOPE: DATE CONTACTED: 02OCT2019 THROUGH 02OCT2019/ MANUFACTURING SITE: PFIZER ALBANY/COMPLAINT CLASS: PRODUCT USE ATTRIBUTES/ COMPLAINT SUB CLASS: PRODUCT USE ATTRIBUTES DEFECT NOT CLASSIFIED. THE CITI SEARCH RETURNED A TOTAL 8 COMPLAINT FOR THE LOWER BACK/HIP (LBH) 8HR PRODUCTS DURING THIS TIME PERIOD FOR THE CLASS/SUBCLASS PRODUCT USE ATTRIBUTES DEFECT NOT CLASSIFIED. NONE WERE CONFIRMED TO HAVE A MANUFACTURING PROCESS ROOT CAUSE FOR A COMPLAINT OF PRODUCT USE ATTRIBUTES DEFECT NOT CLASSIFIED. A CITI COMPLAINT TREND SEARCH WAS CONDUCTED FOR THE SUBCLASS PRODUCT USE ATTRIBUTES DEFECT NOT CLASSIFIED FOR LBH 8HR PRODUCTS. THE DATA DID NOT SHOW AN INCREASE OVER TIME (36 MONTHS). THERE IS NOT A TREND IDENTIFIED FOR THE SUBCLASS PRODUCT USE ATTRIBUTES DEFECT NOT CLASSIFIED FOR LBH 8HR PRODUCTS, REFER TO THE ATTACHED TREND CHART FOR 02OCTOBER2016 - 02OCTOBER2019. THERE IS NO FURTHER ACTION REQUIRED.

    Description of Event or Problem · 0

    EVENT VERBATIM [PREFERRED TERM] CALLER STATES THERMACARE LOWER BACK WRAPS STAYED HOT LONGER THAN THE 8 HOURS [DEVICE ISSUE] , SHE DID WEAR IT CLOSER TO 9 HOURS [INTENTIONAL DEVICE MISUSE] , . CASE NARRATIVE:THIS IS A SPONTANEOUS REPORT FROM A NON-CONTACTABLE CONSUMER. A FEMALE PATIENT OF AN UNSPECIFIED AGE STARTED TO RECEIVE THERMACARE HEATWRAP (THERMACARE LOWER BACK & HIP), FROM AN UNSPECIFIED DATE AT UNKNOWN FREQUENCY FOR AN UNSPECIFIED INDICATION. MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PATIENT REPORTED THAT THE THERMACARE LOWER BACK WRAPS STAYED HOT LONGER THAN THE 8 HOURS. SHE DID WEAR IT CLOSER TO 9 HOURS. BUT SHE WON'T DO THAT ANYMORE. SHE ALSO ASKED HOW TO DISPOSE OF THE WRAPS AFTER SHE IS DONE WITH IT. THE ACTION TAKEN WITH THERMACARE HEATWRAP AND THE OUTCOME OF THE EVENTS WAS UNKNOWN. ACCORDING TO THE PRODUCT QUALITY COMPLAINT GROUP: CONCLUSION: THE ROOT CAUSE CATEGORY IS NON-ASSIGNABLE (COMPLAINT NOT CONFIRMED AS A QUALITY DEFECT). THERE WAS LIMITED DEVICE SPECIFIC INFORMATION PROVIDED, NO 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. THERE IS NOT A PRODUCT QUALITY RELATED TREND IDENTIFIED FOR THE SUBCLASS PRODUCT USE ATTRIBUTES DEFECT NOT CLASSIFIED. THE MANUFACTURING OPERATIONS EMPLOY QUALITY CONTROL PROCEDURES WHICH INCLUDE IN PROCESS TESTING, THERMAL TESTING AND VISUAL INSPECTION, TO ENSURE THE QUALITY OF THE PRODUCT BEING PACKAGED. OTHER TREND ASSMT. & RATIONALE: AN EVALUATION WAS MADE BY SEARCHING FOR POSSIBLE TRENDS FOR THIS SUBCLASS REQUIRING INVESTIGATION BY THE SITE. THE FOLLOWING COMPLAINT INTAKE, TRIAGE AND INVESTIGATION (CITI) SEARCH WAS PERFORMED: SCOPE: DATE CONTACTED: 02OCT2019 THROUGH 02OCT2019/ MANUFACTURING SITE: PFIZER ALBANY/COMPLAINT CLASS: PRODUCT USE ATTRIBUTES/ COMPLAINT SUB CLASS: PRODUCT USE ATTRIBUTES DEFECT NOT CLASSIFIED. THE CITI SEARCH RETURNED A TOTAL 8 COMPLAINT FOR THE LOWER BACK/HIP (LBH) 8HR PRODUCTS DURING THIS TIME PERIOD FOR THE CLASS/SUBCLASS PRODUCT USE ATTRIBUTES DEFECT NOT CLASSIFIED. NONE WERE CONFIRMED TO HAVE A MANUFACTURING PROCESS ROOT CAUSE FOR A COMPLAINT OF PRODUCT USE ATTRIBUTES DEFECT NOT CLASSIFIED. A CITI COMPLAINT TREND SEARCH WAS CONDUCTED FOR THE SUBCLASS PRODUCT USE ATTRIBUTES DEFECT NOT CLASSIFIED FOR LBH 8HR PRODUCTS. THE DATA DID NOT SHOW AN INCREASE OVER TIME (36 MONTHS). THERE IS NOT A TREND IDENTIFIED FOR THE SUBCLASS PRODUCT USE ATTRIBUTES DEFECT NOT CLASSIFIED FOR LBH 8HR PRODUCTS, REFER TO THE ATTACHED TREND CHART FOR 02OCTOBER2016 - 02OCTOBER2019. THERE IS NO FURTHER ACTION REQUIRED. FOLLOW-UP (30OCT2019): NEW INFORMATION RECEIVED FROM THE PRODUCT QUALITY COMPLAINT GROUP INCLUDES INVESTIGATIONAL RESULTS. NO FOLLOW-UP ATTEMPTS ARE POSSIBLE. NO FURTHER INFORMATION IS EXPECTED. COMPANY CLINICAL EVALUATION COMMENT: BASED ON THE AVAILABLE INFORMATION, THE PATIENT REPORTED "THERMACARE LOWER BACK WRAPS STAYED HOT LONGER THAN THE 8 HOURS. SHE DID WEAR IT CLOSER TO 9 HOURS." NO ADVERSE EVENT WAS ASSOCIATED WITH THE USE OF THE DEVICE. THIS IS A SINGLE POTENTIAL DEVICE MALFUNCTION WHICH HAS A THEORETICAL RISK TO CAUSE SKIN BURN. IN THE CASE NARRATIVE, THERE IS EVIDENCE OF DEVICE MISUSE WHICH MOST LIKELY CONTRIBUTED TO THIS INCIDENT. THIS CASE WILL BE RE-ASSESSED SHOULD ADDITIONAL INFORMATION BECOMES AVAILABLE. THERE WAS LIMITED DEVICE SPECIFIC INFORMATION PROVIDED, NO 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. PRODUCT EFFECT VARIES WITH EACH INDIVIDUAL. NO REMEDIAL ACTION/CORRECTIVE ACTION/FIELD SAFETY CORRECTIVE ACTION IS SUGGESTED AT THIS TIME., COMMENT: BASED ON THE AVAILABLE INFORMATION, THE PATIENT REPORTED "THERMACARE LOWER BACK WRAPS STAYED HOT LONGER THAN THE 8 HOURS. SHE DID WEAR IT CLOSER TO 9 HOURS." NO ADVERSE EVENT WAS ASSOCIATED WITH THE USE OF THE DEVICE. THIS IS A SINGLE POTENTIAL DEVICE MALFUNCTION WHICH HAS A THEORETICAL RISK TO CAUSE SKIN BURN. IN THE CASE NARRATIVE, THERE IS EVIDENCE OF DEVICE MISUSE WHICH MOST LIKELY CONTRIBUTED TO THIS INCIDENT. THIS CASE WILL BE RE-ASSESSED SHOULD ADDITIONAL INFORMATION BECOMES AVAILABLE. THERE WAS LIMITED DEVICE SPECIFIC INFORMATION PROVIDED, NO 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. PRODUCT EFFECT VARIES WITH EACH INDIVIDUAL. NO REMEDIAL ACTION/CORRECTIVE ACTION/FIELD SAFETY CORRECTIVE ACTION IS SUGGESTED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER STATES THERMACARE LOWER BACK WRAPS STAYED HOT LONGER THAN THE 8 HOURS [DEVICE ISSUE], SHE DID WEAR IT CLOSER TO 9 HOURS [INTENTIONAL DEVICE MISUSE]. THIS IS A SPONTANEOUS REPORT FROM A NON-CONTACTABLE CONSUMER. A FEMALE PATIENT OF AN UNSPECIFIED AGE STARTED TO RECEIVE THERMACARE HEATWRAP (THERMACARE LOWER BACK & HIP), VIA AN UNSPECIFIED AREA OF ADMINISTRATION, FROM AN UNSPECIFIED DATE, FOR AN UNSPECIFIED INDICATION. MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PATIENT REPORTED THAT THE THERMACARE LOWER BACK WRAPS STAYED HOT LONGER THAN THE 8 HOURS. SHE DID WEAR IT CLOSER TO 9 HOURS. BUT SHE WON'T DO THAT ANYMORE. SHE ALSO ASKED HOW TO DISPOSE OF THE WRAPS AFTER SHE IS DONE WITH IT. THE ACTION TAKEN WITH THERMACARE HEATWRAP AND THE OUTCOME OF THE EVENT WAS NOT REPORTED. NO FOLLOW-UP ATTEMPTS ARE POSSIBLE. NO FURTHER INFORMATION IS EXPECTED. COMPANY CLINICAL EVALUATION COMMENT: BASED ON THE AVAILABLE INFORMATION, THE PATIENT REPORTED "THERMACARE LOWER BACK WRAPS STAYED HOT LONGER THAN THE 8 HOURS. SHE DID WEAR IT CLOSER TO 9 HOURS." NO ADVERSE EVENT WAS ASSOCIATED WITH THE USE OF THE DEVICE. THIS IS A SINGLE POTENTIAL DEVICE MALFUNCTION WHICH HAS A THEORETICAL RISK TO CAUSE SKIN BURN. IN THE CASE NARRATIVE, THERE IS EVIDENCE OF DEVICE MISUSE WHICH MOST LIKELY CONTRIBUTED TO THIS INCIDENT. THIS CASE WILL BE RE-ASSESSED SHOULD ADDITIONAL INFORMATION BECOMES AVAILABLE. COMMENT: BASED ON THE AVAILABLE INFORMATION, THE PATIENT REPORTED "THERMACARE LOWER BACK WRAPS STAYED HOT LONGER THAN THE 8 HOURS. SHE DID WEAR IT CLOSER TO 9 HOURS." NO ADVERSE EVENT WAS ASSOCIATED WITH THE USE OF THE DEVICE. THIS IS A SINGLE POTENTIAL DEVICE MALFUNCTION WHICH HAS A THEORETICAL RISK TO CAUSE SKIN BURN. IN THE CASE NARRATIVE, THERE IS EVIDENCE OF DEVICE MISUSE WHICH MOST LIKELY CONTRIBUTED TO THIS INCIDENT. THIS CASE WILL BE RE-ASSESSED SHOULD ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1059569 THERMACARE LOWER BACK & HIP DISPOSABLE PACK, HOT IMD PFIZER CONSUMER HEALTH CARE

    Patients

    Seq Age Sex Outcome Treatment
    1