BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMACARE HEATWRAP

    MDR report key: 10762546 · Received October 30, 2020

    Report

    Report Number
    1066015-2020-00182
    Event Type
    Malfunction
    Date Received
    October 30, 2020
    Report Date
    October 26, 2020
    Manufacturer
    PFIZER CONSUMER HEALTH CARE
    Product Code
    IMD
    PMA / PMN Number
    K953442
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SITE SAMPLE STATUS: NOT RECEIVED. PROCESS RELATED WAS NO. FINAL CONFIRMATION STATUS WAS NOT CONFIRMED. SUMMARY OF INVESTIGATION: THIS INVESTIGATION WAS CONDUCTED FOR AN UNKNOWN LOT NUMBER LOWER BACK/HIP (LBH) 8-HOUR PRODUCT. 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, 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 WRAP/PATCH/PAD TOO HOT. 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. LOT TREND ASSMT. & RATIONALE: A LOT TREND WAS NOT PERFORMED AS THE LOT NUMBER IS UNKNOWN. EXPED TREND ASSMT. & RATIONALE: AN EVALUATION WAS MADE BY SEARCHING FOR POSSIBLE TREND FOR THIS SUBCLASS. EXPED TREND ACTIONS TAKEN: BASED ON THIS CITI CUSTOMIZABLE SEARCH FOR THE SUBCLASSES OF WRAP/PATCH/PAD TOO HOT FOR LBH PRODUCTS THE DATA DID NOT SHOW AN INCREASE OVER TIME (36 MONTHS). NO TREND IDENTIFIED FOR THE SUBCLASS OF WRAP/PATCH/PAD TOO HOT FOR LBH PRODUCT, REFER TO THE ATTACHED TREND CHART: LBH WRAP/PATCH/PAD TOO HOT 26OCT2017 TO 26OCT2020.

    Description of Event or Problem · 0

    EVENT VERBATIM [PREFERRED TERM] GETS WAY TOO HOT AND THE SMELL IS VERY STRONG [DEVICE ISSUE]. NARRATIVE: THIS IS A SPONTANEOUS REPORT FROM A NON-CONTACTABLE CONSUMER. A PATIENT OF UNSPECIFIED AGE AND GENDER STARTED TO RECEIVE THERMACARE HEATWRAP (THERMACARE HEATWRAP), FROM AN UNSPECIFIED DATE AT AN UNSPECIFIED FREQUENCY FOR AN UNSPECIFIED INDICATION. THE PATIENT MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PATIENT STATED "GETS WAY TOO HOT AND THE SMELL IS VERY STRONG". THE ACTION TAKEN IN RESPONSE TO THE EVENT FOR THE PRODUCT WAS UNKNOWN. THE EVENT OUTCOME WAS UNKNOWN. ACCORDING TO PRODUCT QUALITY COMPLAINTS: SITE SAMPLE STATUS: NOT RECEIVED. PROCESS RELATED WAS NO. FINAL CONFIRMATION STATUS WAS NOT CONFIRMED. SUMMARY OF INVESTIGATION: THIS INVESTIGATION WAS CONDUCTED FOR AN UNKNOWN LOT NUMBER LOWER BACK/HIP (LBH) 8-HOUR PRODUCT. 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, 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 WRAP/PATCH/PAD TOO HOT. 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. LOT TREND ASSMT. & RATIONALE: A LOT TREND WAS NOT PERFORMED AS THE LOT NUMBER IS UNKNOWN. EXPED TREND ASSMT. & RATIONALE: AN EVALUATION WAS MADE BY SEARCHING FOR POSSIBLE TREND FOR THIS SUBCLASS. EXPED TREND ACTIONS TAKEN: BASED ON THIS CITI CUSTOMIZABLE SEARCH FOR THE SUBCLASSES OF WRAP/PATCH/PAD TOO HOT FOR LBH PRODUCTS THE DATA DID NOT SHOW AN INCREASE OVER TIME (36 MONTHS). NO TREND IDENTIFIED FOR THE SUBCLASS OF WRAP/PATCH/PAD TOO HOT FOR LBH PRODUCT, REFER TO THE ATTACHED TREND CHART: LBH WRAP/PATCH/PAD TOO HOT 26OCT2017 TO 26OCT2020. FOLLOW-UP (27OCT2020): NO FOLLOW-UP ATTEMPTS ARE POSSIBLE. NO FURTHER INFORMATION IS EXPECTED. FOLLOW-UP (30OCT2020): NEW INFORMATION RECEIVED FROM PRODUCT QUALITY COMPLAINTS INCLUDES INVESTIGATION RESULTS. NO FOLLOW-UP ATTEMPTS ARE POSSIBLE. NO FURTHER INFORMATION IS EXPECTED.

    Description of Event or Problem · 1

    GETS WAY TOO HOT AND THE SMELL IS VERY STRONG [DEVICE ISSUE]. NARRATIVE: THIS IS A SPONTANEOUS REPORT FROM A NON-CONTACTABLE CONSUMER. A PATIENT OF UNSPECIFIED AGE AND GENDER STARTED TO RECEIVE THERMACARE HEATWRAP (THERMACARE HEATWRAP), FROM AN UNSPECIFIED DATE AT AN UNSPECIFIED FREQUENCY FOR AN UNSPECIFIED INDICATION. THE PATIENT MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PATIENT STATED "GETS WAY TOO HOT AND THE SMELL IS VERY STRONG". THE ACTION TAKEN IN RESPONSE TO THE EVENT FOR THE PRODUCT WAS UNKNOWN. THE EVENT OUTCOME WAS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE PROVIDED AS IT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1231704 THERMACARE HEATWRAP DISPOSABLE PACK, HOT IMD PFIZER CONSUMER HEALTH CARE

    Patients

    Seq Age Sex Outcome Treatment
    1