BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMACARE LOWER BACK & HIP

    MDR report key: 9263354 · Received October 31, 2019

    Report

    Report Number
    1066015-2019-00445
    Event Type
    Malfunction
    Date Received
    October 31, 2019
    Report Date
    December 4, 2018
    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
    003

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE ROOT CAUSE CATEGORY IS NON-ASSIGNABLE (COMPLAINT NOT CONFIRMED). OUR 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. NO TREND HAS BEEN IDENTIFIED FOR LBH PRODUCT FOR THE SUBCLASS OF CELLS DAMAGED/LEAKING. INITIAL COMPLAINT ASSESSMENT THE PCOM SEARCH RETURNED A TOTAL OF 61 COMPLAINTS FOR LOWER BACK AND HIP PRODUCTS DURING THIS TIME PERIOD FOR THE CLASS/SUBCLASS. OF THE 61 COMPLAINTS; 22 COMPLAINTS HAVE THE BATCH NUMBER RECORDED AS ¿UNKNOWN¿. THE 39 REMAINING COMPLAINTS WERE EVALUATED. THERE WERE NINE COMPLAINTS CONFIRMED TO HAVE A MANUFACTURING PROCESS ROOT CAUSE FOR THE COMPLAINT OF CELLS DAMAGED/LEAKING. BASED ON THIS PCOM SEARCH FOR THE SUBCLASS OF CELLS DAMAGED/LEAKING FOR LBH PRODUCTS THE DATA DID NOT SHOW AN INCREASE OVER TIME (36 MONTHS). THERE IS NOT A TREND IDENTIFIED FOR THE SUBCLASS CELL DAMAGED/LEAKING FOR LBH PRODUCTS.

    Description of Event or Problem · 1

    TWO OF THE HEATWRAPS SHE PURCHASED FOR HER DAUGHTER WAS BUSTED AND HER DAUGHTER WAS UNABLE TO USE THEM, DEVICE LEAKAGE. 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 & HIPHEATWRAP), (DEVICE LOT NUMBER AND EXPIRATION DATE WAS NOT PROVIDED), VIA AN UNSPECIFIED AREA OF ADMINISTRATION, FROM AN UNSPECIFIED DATE, FOR AN UNSPECIFIED INDICATION. MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE CONSUMER STATED TWO OF THE HEATWRAPS SHE PURCHASED FOR HER DAUGHTER WERE "BUSTED" AND HER DAUGHTER WAS UNABLE TO USE THEM; THE MOTHER DIDN'T HAVE ANY OTHER INFORMATION TO GIVE. THE ACTION TAKEN WITH THERMACARE HEATWRAP AND THE OUTCOME OF THE EVENT WAS NOT REPORTED. THE PRODUCT QUALITY GROUP REPORTED THAT: THE ROOT CAUSE CATEGORY IS NON-ASSIGNABLE (COMPLAINT NOT CONFIRMED). OUR 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. NO TREND HAS BEEN IDENTIFIED FOR LBH PRODUCT FOR THE SUBCLASS OF CELLS DAMAGED/LEAKING. INITIAL COMPLAINT ASSESSMENT THE PCOM SEARCH RETURNED A TOTAL OF 61 COMPLAINTS FOR LOWER BACK AND HIP PRODUCTS DURING THIS TIME PERIOD FOR THE CLASS/SUBCLASS. OF THE 61 COMPLAINTS; 22 COMPLAINTS HAVE THE BATCH NUMBER RECORDED AS 'UNKNOWN'. THE 39 REMAINING COMPLAINTS WERE EVALUATED. THERE WERE NINE COMPLAINTS CONFIRMED TO HAVE A MANUFACTURING PROCESS ROOT CAUSE FOR THE COMPLAINT OF CELLS DAMAGED/LEAKING. BASED ON THIS PCOM SEARCH FOR THE SUBCLASS OF CELLS DAMAGED/LEAKING FOR LBH PRODUCTS THE DATA DID NOT SHOW AN INCREASE OVER TIME (36 MONTHS). THERE IS NOT A TREND IDENTIFIED FOR THE SUBCLASS CELL DAMAGED/LEAKING FOR LBH PRODUCTS. NO FOLLOW UP ATTEMPTS ARE POSSIBLE. NO FURTHER INFORMATION IS EXPECTED. COMPANY CLINICAL EVALUATION COMMENT : THE PATIENT REPORTED THAT TWO OF THE HEATWRAPS SHE PURCHASED FOR HER DAUGHTER WAS BUSTED AND HER DAUGHTER WAS UNABLE TO USE THEM. THIS IS A SINGLE POTENTIAL DEVICE MALFUNCTION WHICH HAS A THEORETICAL RISK TO CAUSE SKIN BURN. NO OTHER ADVERSE EVENT SUCH AS BURN WAS ASSOCIATED WITH THE USE OF THE DEVICE. THE EVENT IS MEDICALLY ASSESSED AS ASSOCIATED WITH THE USE OF THE DEVICE. THE COMPANY IS CONDUCTING FURTHER REVIEW ON THIS INVESTIGATION AND ADDITIONAL FOLLOW-UP WILL BE REPORTED WHEN THE EVALUATION IS COMPLETED., COMMENT: THE PATIENT REPORTED THAT TWO OF THE HEATWRAPS SHE PURCHASED FOR HER DAUGHTER WAS BUSTED AND HER DAUGHTER WAS UNABLE TO USE THEM. THIS IS A SINGLE POTENTIAL DEVICE MALFUNCTION WHICH HAS A THEORETICAL RISK TO CAUSE SKIN BURN. NO OTHER ADVERSE EVENT SUCH AS BURN WAS ASSOCIATED WITH THE USE OF THE DEVICE. THE EVENT IS MEDICALLY ASSESSED AS ASSOCIATED WITH THE USE OF THE DEVICE. THE COMPANY IS CONDUCTING FURTHER REVIEW ON THIS INVESTIGATION AND ADDITIONAL FOLLOW-UP WILL BE REPORTED WHEN THE EVALUATION IS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1053580 THERMACARE LOWER BACK & HIP DISPOSABLE PACK, HOT IMD PFIZER CONSUMER HEALTH CARE

    Patients

    Seq Age Sex Outcome Treatment
    1