BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACARE LOWER BACK & HIP

    MDR report key: 9261088 · Received October 31, 2019

    Report

    Report Number
    1066015-2019-00391
    Event Type
    Injury
    Date Received
    October 31, 2019
    Date of Event
    February 25, 2019
    Report Date
    February 27, 2019
    Manufacturer
    PFIZER CONSUMER HEALTH CARE
    Product Code
    IMD
    PMA / PMN Number
    K953442
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 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 PRODUCT BEING PACKAGED. SEVERITY RANKING: S3. ADDITIONAL INFORMATION RECEIVED FROM PRODUCT QUALITY COMPLAINT (PQC) GROUP INCLUDED INVESTIGATION RESULTS ON 23OCT2019 IN REVIEW OF THE 36 MONTH TREND CHART FOR BATCHES WITH UNKNOWN BATCH NUMBERS SHOWS A SPIKE IN APRIL AND MAY2019. THE MAJORITY OF THE COMPLAINTS BY DESCRIPTION HAVE A SEVERITY RANKING OF S1-TOO COOL, HEAT/COLD DID NOT LAST LONG ENOUGH, NEVER WORKED, SQUEEZE TUBE POUCH DAMAGE DEFECT PER HAZARD ANALYSIS, THERMACARE HEAT WRAP PRODUCT: 8 AND 12HR. THIS IS ALSO OBSERVED IN A REVIEW OF THE 24 MONTH TREND CHART FOR THIS SUBCLASS. THESE COMPLAINTS ARE CLASSIFIED AS AN OPEN-POUCH. ALL OPEN POUCH COMPLAINTS ARE INVESTIGATED AND ARE NOT VALID ADVERSE EVENTS. BASED ON THIS CITI CUSTOMIZABLE SEARCH FOR THE SUBCLASSES OF ADVERSE EVENT/SERIOUS/UNKNOWN, ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION AND ADVERSE NEGLIGIBLE-MINOR FOR LBH PRODUCTS THE DATA DID NOT SHOW AN INCREASE OVER TIME (36 MONTHS). THERE IS NOT A TREND IDENTIFIED FOR THE SUBCLASS OF ADVERSE EVENT/SERIOUS/UNKNOWN, ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION AND ADVERSE NEGLIGIBLE-MINOR FOR LBH PRODUCT, REFER TO ATTACHMENT UNKNOWN LBH ADVERSE EVENT 15AUG2016 TO 15AUG2019. EXPED TREND ACTIONS TAKEN: BASED ON THIS CITI CUSTOMIZABLE SEARCH FOR THE SUBCLASSES OF ADVERSE EVENT/SERIOUS/UNKNOWN, ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION.

    Description of Event or Problem · 1

    EVENT VERBATIM [PREFERRED TERM] NOTICED BLISTER ON BACK YESTERDAY [BLISTER] , WEARING IT FOR 14-15 HOURS/SHE WAS SLEEPING WHILE WEARING THE HEATWRAP AND WAS WEARING SEVERAL LAYERS OF CLOTHING OVER IT/DID NOT CHECK HER SKIN UNDER THE THERMACARE [DEVICE USE ERROR]. CASE NARRATIVE:THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER. A (B)(6) FEMALE PATIENT STARTED TO USE THERMACARE HEATWRAP (THERMACARE LOWER BACK & HIP) APPLIED TO HER LOWER BACK FROM (B)(6) 2019 FOR BACKACHE, LOWER BACK PAIN AND STIFFNESS. THE COLOR OF THE BOX WAS RED. MEDICAL HISTORY INCLUDED BLOOD PRESSURE ISSUES AND IS POST-MENOPAUSAL. CONCOMITANT MEDICATIONS INCLUDE UNSPECIFIED BLOOD PRESSURE PILLS AND OTHER ROUTINE MEDICATIONS. THE PATIENT USED THERMACARE A COUPLE OF YEARS AGO FOR 12 HOURS OVERNIGHT AND EXPERIENCED NO PROBLEMS. SHE HAD USED OTHER HEAT PRODUCTS FOR PAIN RELIEF MORE THAN A YEAR AGO. THE PATIENT REPORTED THAT SHE WOULD BE ON A PLANE FOR 14 HOURS AND HAD A BACKACHE. ON (B)(6) 2019, SHE PUT THE HEATWRAP ON HER LOWER BACK. ON (B)(6) 2019, SHE TOOK OFF THE WRAP AFTER WEARING IT FOR 14-15 HOURS AND THEN 10-20 MINUTES LATER, NOTICED A BLISTER. SHE DID NOT NOTICE THE BLISTER UNTIL LATE AT NIGHT AND SHE SAID THAT SHE WOULD LEAVE IT ALONE AND DID NOT WANT TO POP IT DUE TO FEAR THAT IT WOULD GET WORSE. THE PATIENT DENIED HAVING DIABETES, POOR CIRCULATION, HEART DISEASE, DIFFICULTY FEELING HEAT OR PAIN ON THE SKIN, RHEUMATOID ARTHRITIS, DECREASED SENSATION, OR NEUROPATHY. SHE DESCRIBES HER SKIN TONE AS MEDIUM (NEITHER LIGHT NOR DARK) AND DID NOT HAVE SENSITIVE SKIN OR ANY ABNORMAL SKIN CONDITIONS. SHE STATED THAT SHE WAS SLEEPING WHILE WEARING THE HEATWRAP AND WAS WEARING SEVERAL LAYERS OF CLOTHING OVER IT. SHE ATTACHED THE ADHESIVE TO BODY. SHE DID NOT ENGAGE IN EXERCISE WHILE WEARING THE HEATWRAP AS SHE WAS ON A PLANE, SLEEPING. SHE DID NOT CHECK HER SKIN UNDER THE THERMACARE AND DID NOT READ THE USAGE INSTRUCTIONS BEFORE USING IT. SHE DID NOT HAVE THE LOT NUMBER OR EXPIRATION DATE AS SHE THREW IT AWAY. THERE WAS NO PRODUCT REMAINING. SHE DID NOT HAVE ANY TREATMENT FOR THE BLISTER AND DID NOT CONSULT A HEALTHCARE PROFESSIONAL. NO ADMISSION TO HOSPITAL INVOLVED. THE SKIN BLISTERING STARTED FOR 5-7 DAYS. THE ACTION TAKEN WITH THE HEAT WRAP WAS PERMANENTLY WITHDRAWN ON (B)(6) 2019. THE OUTCOME OF THE BLISTER WAS RESOLVED IN (B)(6) 2019 AND THE OUTCOME OF THE REMAINING EVENT WAS UNKNOWN. INFORMATION RECEIVED FROM PRODUCT QUALITY COMPLAINT (PQC) GROUP 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 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 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 PRODUCT BEING PACKAGED. SEVERITY RANKING: S3. ADDITIONAL INFORMATION RECEIVED FROM PRODUCT QUALITY COMPLAINT (PQC) GROUP INCLUDED INVESTIGATION RESULTS ON 23OCT2019 IN REVIEW OF THE 36 MONTH TREND CHART FOR BATCHES WITH UNKNOWN BATCH NUMBERS SHOWS A SPIKE IN APRIL AND MAY2019. THE MAJORITY OF THE COMPLAINTS BY DESCRIPTION HAVE A SEVERITY RANKING OF S1-TOO COOL, HEAT/COLD DID NOT LAST LONG ENOUGH, NEVER WORKED, SQUEEZE TUBE POUCH DAMAGE DEFECT PER HAZARD ANALYSIS, THERMACARE HEAT WRAP PRODUCT: 8 AND 12HR. THIS IS ALSO OBSERVED IN A REVIEW OF THE 24 MONTH TREND CHART FOR THIS SUBCLASS. THESE COMPLAINTS ARE CLASSIFIED AS AN OPEN-POUCH. ALL OPEN POUCH COMPLAINTS ARE INVESTIGATED AND ARE NOT VALID ADVERSE EVENTS. BASED ON THIS CITI CUSTOMIZABLE SEARCH FOR THE SUBCLASSES OF ADVERSE EVENT/SERIOUS/UNKNOWN, ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION AND ADVERSE NEGLIGIBLE-MINOR FOR LBH PRODUCTS THE DATA DID NOT SHOW AN INCREASE OVER TIME (36 MONTHS). THERE IS NOT A TREND IDENTIFIED FOR THE SUBCLASS OF ADVERSE EVENT/SERIOUS/UNKNOWN, ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION AND ADVERSE NEGLIGIBLE-MINOR FOR LBH PRODUCT, REFER TO ATTACHMENT UNKNOWN LBH ADVERSE EVENT 15AUG2016 TO 15AUG2019. EXPED TREND ACTIONS TAKEN: BASED ON THIS CITI CUSTOMIZABLE SEARCH FOR THE SUBCLASSES OF ADVERSE EVENT/SERIOUS/UNKNOWN, ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION AND ADVERSE NEGLIGIBLE-MINOR FOR LBH PRODUCTS THE DATA DID NOT SHOW AN INCREASE OVER TIME (36 MONTHS). THERE IS NOT A TREND IDENTIFIED FOR THE SUBCLASS OF ADVERSE EVENT/SERIOUS/UNKNOWN. REVIEW OF COMPLAINT DESCRIPTION CONCLUDES THERE IS NO DEVICE MALFUNCTION. FOLLOW-UP (03MAY2019): NEW INFORMATION RECEIVED FROM A CONTACTABLE CONSUMER INCLUDES DEVICE DATA (INDICATION, STOP DATE, ACTION TAKEN), NEW EVENT (ATTACHED THE ADHESIVE TO BODY), OUTCOME OF EVENT, STOP DATE OF EVENT AND DENIAL OF HOSPITALIZATION. FOLLOW-UP ATTEMPTS ARE COMPLETED. NO FURTHER INFORMATION IS EXPECTED. FOLLOW-UP (29JUL2019): NEW INFORMATION RECEIVED FROM PRODUCT QUALITY COMPLAINTS (PQC) GROUP INCLUDED: SEVERITY RANKING: S3. FOLLOW-UP (30AUG2019): NEW INFORMATION RECEIVED FROM PRODUCT QUALITY COMPLAINTS (PQC) GROUP INCLUDED: PRODUCT QUALITY INVESTIGATION RESULTS. FOLLOW-UP 23OCT2019): NEW INFORMATION RECEIVED FROM PRODUCT QUALITY COMPLAINTS (PQC) GROUP INCLUDED: ADDITIONAL PRODUCT QUALITY INVESTIGATION RESULTS. FOLLOW-UP (27FEB2019): THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO UPGRADE THIS CASE TO A REPORTABLE MDR. COMPANY CLINICAL EVALUATION COMMENT: BASED ON THE INFORMATION PROVIDED, THE EVENTS BLISTER AND DEVICE USE ERROR AS DESCRIBED ARE CONSIDERED SERIOUS BODILY INJURY POTENTIALLY REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT DAMAGE OR IMPAIRMENT OF BODY STRUCTURE. THE EVENTS ARE MEDICALLY ASSESSED AS ASSOCIATED WITH THE USE OF THE DEVICE., COMMENT: BASED ON THE INFORMATION PROVIDED, THE EVENTS BLISTER AND DEVICE USE ERROR AS DESCRIBED ARE CONSIDERED SERIOUS BODILY INJURY POTENTIALLY REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT DAMAGE OR IMPAIRMENT OF BODY STRUCTURE. THE EVENTS ARE MEDICALLY ASSESSED AS ASSOCIATED WITH THE USE OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1053527 THERMACARE LOWER BACK & HIP DISPOSABLE PACK, HOT IMD PFIZER CONSUMER HEALTH CARE

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention