BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACARE LOWER BACK & HIP

    MDR report key: 10905084 · Received November 25, 2020

    Report

    Report Number
    1066015-2020-00199
    Event Type
    Injury
    Date Received
    November 25, 2020
    Report Date
    November 18, 2020
    Manufacturer
    PFIZER CONSUMER HEALTH CARE
    Product Code
    IMD
    PMA / PMN Number
    K953442
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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 OR A 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 ADVERSE EVENT/SERIOUS/UNKNOWN. THE MANUFACTURING OPERATIONS EMPLOY QUALITY CONTROL PROCEDURES, WHICH INCLUDE IN-PROCESS TESTING, THERMAL TESTING, AND VISUAL INSPECTION, TO ENSURE THE QUALITY OF THE PACKAGED PRODUCT. REASONABLY SUGGEST DEVICE MALFUNCTION: NO. SEVERITY OF HARM: N/A. SITE SAMPLE STATUS: NOT RECEIVED.

    Description of Event or Problem · 0

    EVENT VERBATIM [PREFERRED TERM] SKIN BURNS WHEN WEARING THERMACARE TOO LONG [DEVICE USE ERROR], SKIN BURNS WHEN WEARING THERMACARE TOO LONG [THERMAL BURN], , NARRATIVE: THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER BASED ON INFORMATION RECEIVED BY PFIZER FROM ANGELINI (INTAKE ID: AT4591), LICENSE PARTY FOR THERMACARE. THIS INFORMATION ORIGINATES FROM A MARKET SURVEY WITH A FOCUS ON THE THERMACARE MEDICAL DEVICE IS BEING CONDUCTING BY THE ANGELINI GLOBAL MARKETING THROUGH THE SERVICE PROVIDER TOLUNA INC. TOLUNA REFERENCE NUMBER:(B)(4).A 37-YEAR-OLD MALE PATIENT STARTED TO RECEIVE THERMACARE HEATWRAP (THERMACARE HEATWRAP), VIA AN UNSPECIFIED ROUTE OF ADMINISTRATION FROM AN UNSPECIFIED DATE AT AN UNSPECIFIED DOSE FOR AN UNSPECIFIED INDICATION. THE PATIENT MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PATIENT EXPERIENCED SKIN BURNS WHEN WEARING THERMACARE TOO LONG. IT WAS NOT REPORTED, WHETHER THE EVENT WAS SERIOUS AND WHETHER THE REPORTER THOUGHT THAT THE PRODUCT CAUSED THE INCIDENT. THE ACTION TAKEN IN RESPONSE TO THE EVENT FOR THERMACARE HEATWRAP AND EVENT OUTCOME WERE UNKNOWN. ACCORDING TO THE PRODUCT QUALITY COMPLAINT GROUP: SEVERITY OF HARM WAS PROVIDED AS S3. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE PROVIDED AS IT BECOMES AVAILABLE. FOLLOW UP (18NOV2020): NEW INFORMATION RECEIVED FROM A PRODUCT QUALITY COMPLAINT GROUP INCLUDED: SEVERITY OF HARM RATING ASSESSMENT FROM DCHU.

    Description of Event or Problem · 0

    EVENT VERBATIM [PREFERRED TERM] SKIN BURNS WHEN WEARING THERMACARE TOO LONG [DEVICE USE ERROR], SKIN BURNS WHEN WEARING THERMACARE TOO LONG [THERMAL BURN], NARRATIVE: THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER BASED ON INFORMATION RECEIVED BY PFIZER FROM ANGELINI (INTAKE ID: (B)(4), LICENSE PARTY FOR THERMACARE. THIS INFORMATION ORIGINATES FROM A MARKET SURVEY WITH A FOCUS ON THE THERMACARE MEDICAL DEVICE IS BEING CONDUCTING BY THE ANGELINI GLOBAL MARKETING THROUGH THE SERVICE PROVIDER TOLUNA INC. TOLUNA REFERENCE NUMBER:(B)(4). A 37-YEAR-OLD MALE PATIENT STARTED TO USE THERMACARE HEATWRAP (THERMACARE LOWER BACK & HIP) FROM AN UNSPECIFIED DATE FOR AN UNSPECIFIED INDICATION. THE PATIENT'S MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNSPECIFIED DATE, THE PATIENT EXPERIENCED SKIN BURNS WHEN WEARING THERMACARE TOO LONG. IT WAS NOT REPORTED WHETHER THE EVENT WAS SERIOUS AND WHETHER THE REPORTER THOUGHT THAT THE PRODUCT CAUSED THE INCIDENT. ACTION TAKEN IN RESPONSE TO THE EVENT FOR THERMACARE HEATWRAP AND EVENT OUTCOME WERE UNKNOWN. ACCORDING TO THE PRODUCT QUALITY COMPLAINT GROUP: SEVERITY OF HARM WAS PROVIDED AS S3. ADDITIONAL INFORMATION RECEIVED FROM PRODUCT QUALITY COMPLAINT (PQC) GROUP ON (B)(6) 2020, INCLUDED INVESTIGATION RESULTS. 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 OR A 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 ADVERSE EVENT/SERIOUS/UNKNOWN. THE MANUFACTURING OPERATIONS EMPLOY QUALITY CONTROL PROCEDURES, WHICH INCLUDE IN-PROCESS TESTING, THERMAL TESTING, AND VISUAL INSPECTION, TO ENSURE THE QUALITY OF THE PACKAGED PRODUCT. REASONABLY SUGGEST DEVICE MALFUNCTION: NO. SEVERITY OF HARM: N/A. SITE SAMPLE STATUS: NOT RECEIVED. FOLLOW-UP (B)(6) 2020): NEW INFORMATION RECEIVED FROM A PRODUCT QUALITY COMPLAINT GROUP INCLUDED: SEVERITY OF HARM RATING ASSESSMENT FROM DCHU. FOLLOW-UP (03DEC2020): NEW INFORMATION RECEIVED FROM PRODUCT QUALITY COMPLAINTS (PQC) GROUP INCLUDED: PRODUCT QUALITY INVESTIGATION RESULTS AND UPDATED SUSPECT PRODUCT. FOLLOW-UP ACTIVITIES COMPLETED. NO FURTHER INFORMATION EXPECTED.

    Description of Event or Problem · 1

    EVENT VERBATIM: SKIN BURNS WHEN WEARING THERMACARE TOO LONG [DEVICE USE ERROR], SKIN BURNS WHEN WEARING THERMACARE TOO LONG [THERMAL BURN]. NARRATIVE: THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER BASED ON INFORMATION RECEIVED BY PFIZER FROM ANGELINI (INTAKE ID: (B)(4)), LICENSE PARTY FOR THERMACARE. THIS INFORMATION ORIGINATES FROM A MARKET SURVEY WITH A FOCUS ON THE THERMACARE MEDICAL DEVICE IS BEING CONDUCTING BY THE ANGELINI GLOBAL MARKETING THROUGH THE SERVICE PROVIDER TOLUNA INC. TOLUNA REFERENCE NUMBER: (B)(4). A (B)(6)-YEAR-OLD MALE PATIENT STARTED TO RECEIVE THERMACARE HEATWRAP (THERMACARE HEATWRAP), VIA AN UNSPECIFIED ROUTE OF ADMINISTRATION FROM AN UNSPECIFIED DATE AT AN UNSPECIFIED DOSE FOR AN UNSPECIFIED INDICATION. THE PATIENT MEDICAL HISTORY, AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PATIENT EXPERIENCED SKIN BURNS WHEN WEARING THERMACARE TOO LONG. IT WAS NOT REPORTED, WHETHER THE EVENT WAS SERIOUS, AND WHETHER THE REPORTER THOUGHT THAT THE PRODUCT CAUSED THE INCIDENT. THE ACTION TAKEN IN RESPONSE TO THE EVENT FOR THERMACARE HEATWRAP AND 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
    1364420 THERMACARE LOWER BACK & HIP DISPOSABLE PACK, HOT IMD PFIZER CONSUMER HEALTH CARE

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention