BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACARE LOWER BACK & HIP

    MDR report key: 6409046 · Received March 16, 2017

    Report

    Report Number
    1066015-2017-00058
    Event Type
    Injury
    Date Received
    March 16, 2017
    Report Date
    March 9, 2017
    Manufacturer
    PFIZER CONSUMER HEALTH CARE
    Product Code
    IMD
    PMA / PMN Number
    K953442
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE CATEGORY IS NON-ASSIGNABLE (COMPLAINT NOT CONFIRMED). THERE WAS NO MENTION OF ISSUES WITH MATERIAL TRACKING DURING MANUFACTURING OF THE BATCH, THERE WERE NO WRAP ATTRIBUTE DEFECTS RECORDED FOR THE BATCH. 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 QUALITY ISSUES WERE IDENTIFIED UPON THIS REVIEW OF THE BATCH DEVICE HISTORY RECORD, IN PROCESS ATTRIBUTES AND VARIABLE QUALITY CHECKS OR, INSPECTION OF RETAINED SAMPLES. RETAINED SAMPLES MET THE PRODUCT DESCRIPTION AND THE PRODUCT IS WITHIN EXPIRATION DATE. EVALUATION OF THE RETURN SAMPLE SHOWS THAT THIS COMPLAINT IS NOT RELATED TO INVESTIGATION (B)(4) - WEB TRACKING SYSTEM CONFIGURATION FAILURES.

    Description of Event or Problem · 1

    EVENT VERBATIM [PREFERRED TERM] VERY RED AND BLISTERS IN SEVERAL SPOTS [BLISTER], HE GOT BURNS FROM THEM ON HIS BACK [THERMAL BURN]. CASE NARRATIVE: THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER. A MALE PATIENT (RETIRED DENTIST) OF AN UNSPECIFIED AGE AND ETHNICITY STARTED TO RECEIVE THERMACARE HEATWRAP (THERMACARE LOWER BACK & HIP) (DEVICE LOT NUMBER Q01103, EXPIRATION DATE JUL2019) FROM AN UNSPECIFIED DATE FOR PROBABLY 18 YEARS BEFORE FOR SCOLIOSIS AND BAD SPINE. MEDICAL HISTORY INCLUDED PAIN FROM AN UNKNOWN DATE AND UNKNOWN IF ONGOING. CONCOMITANT MEDICATION INCLUDED METAXALONE (SKELAXIN) FOR PAIN. REPORTER MENTIONED THAT HER HUSBAND USED THERMACARE QUITE FREQUENTLY, BUT THEY WERE FALLING APART. THEY SEEMED NOT TO BE MAKING THE ELASTIC PIECE THAT ADHERES. "YOU KNOW THE PIECE THAT GOES AROUND YOUR WAIST THAT SEEMS TO COME IN TWO DIFFERENT IN 1,2,3,4 PARTS. BUT IT IS COMING APART BEFORE YOU CAN EVEN GET THE FULL LAYER OUT OF IT, BEFORE THE DAY IS OVER, IT IS FALLING APART." REPORTER MENTIONED IT LOOSE THE ADHESIVENESS AND THE GRIP, WHATEVER THIS GRIP WAS. "I NOTICED THEM THEY ARE MAKING THE QUALITY IS NOT THE SAME WHICH IT WAS WHEN IT WAS ORIGINALLY CAME OUT. THESE ARE THINNER. THE LAST PIECE THAT GOES AROUND THE WAIST IS THINNER IT IS NOT AS THICK AS IT WAS." REPORTER MENTIONED THAT SHE PUT IT ON OVER HIS T-SHIRT SO THAT IT WAS NOT DIRECTLY NEXT TO HIS BODY. REPORTER MENTIONED THERE WAS NO ONE OTHER THING HER HUSBAND WORE IT TO, BUT SHE NOTICED THAT HE GOT BURNS FROM THEM ON HIS BACK. REPORTER MENTIONED THAT IT WAS NOT THE THIRD DEGREE BURN. IT WAS A VERY RED AND BLISTERS IN SEVERAL SPOTS. REPORTER TREATED HIM WITH SOME FIRST AID, TEA TREE OIL LIKE AN OINTMENT, IT CALMED DOWN BURNING AND AN AQUAPHOR TO REDUCE THE BURNING. REPORTER MENTIONED THAT HE HAD LABORATORY WORK, BUT DID NOT HAVE THE RESULTS RIGHT NOW. THE PATIENT DID NOT HAVE DIABETES, POOR CIRCULATION, HEART DISEASE AND DIFFICULTY FEELING HEAT OR PAIN ON YOUR SKIN AND RHEUMATOID ARTHRITIS AND DECREASED SENSATION AND NEUROPATHY. THE REPORTER CLASSIFIED SKIN TONE OF CONSUMER AS MEDIUM LIGHT. THE CONSUMER DID NOT HAVE SENSITIVE SKIN. THE CONSUMER DID NOT HAVE ANY ABNORMAL SKIN CONDITIONS. THE CONSUMER DID NOT SLEEP WITH IT. THE CONSUMER DID NOT ENGAGE IN EXERCISE WHILE USING THE PRODUCT. THE CONSUMER DID CHECK THE SKIN UNDER THE PRODUCT WHILE WEARING THERMACARE. THE CONSUMER HAD BEEN USING THERMACARE THAT DAY FOR APPROXIMATELY 4 OR 5 HOURS. THE CONSUMER'S DAUGHTER WAS A NURSE AND SHE KIND OF TOLD THE REPORTER WHAT TO DO. REPORTER MENTIONED THAT CONSUMER WAS STILL USING IT. THE ACTION TAKEN IN RESPONSE TO THE EVENTS FOR THERMACARE WAS DOSE NOT CHANGED. THE OUTCOME OF THE EVENTS WAS UNKNOWN. AS OF 25APR2017, THE PRODUCT QUALITY COMPLAINT (PQC) GROUP INVESTIGATION RESULTS STATED THAT THE ROOT CAUSE CATEGORY IS NON-ASSIGNABLE (COMPLAINT NOT CONFIRMED). THERE WAS NO MENTION OF ISSUES WITH MATERIAL TRACKING DURING MANUFACTURING OF THE BATCH, THERE WERE NO WRAP ATTRIBUTE DEFECTS RECORDED FOR THE BATCH. 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 QUALITY ISSUES WERE IDENTIFIED UPON THIS REVIEW OF THE BATCH DEVICE HISTORY RECORD, IN PROCESS ATTRIBUTES AND VARIABLE QUALITY CHECKS OR, INSPECTION OF RETAINED SAMPLES. RETAINED SAMPLES MET THE PRODUCT DESCRIPTION AND THE PRODUCT IS WITHIN EXPIRATION DATE. EVALUATION OF THE RETURN SAMPLE SHOWS THAT THIS COMPLAINT IS NOT RELATED TO INVESTIGATION (B)(4) - WEB TRACKING SYSTEM CONFIGURATION FAILURES. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE PROVIDED AS IT BECOMES AVAILABLE. FOLLOW-UP (25APR2017): NEW INFORMATION REPORTED FROM THE PQC GROUP INCLUDES: PRODUCT TRADE NAME AND INVESTIGATION SUMMARY RESULTS. COMPANY CLINICAL EVALUATION COMMENT: BASED ON THE INFORMATION PROVIDED, THE EVENT "BURN AND BLISTER" AS DESCRIBED IN THIS CASE IS CONSIDERED A SERIOUS BODILY INJURY REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT DAMAGE OR IMPAIRMENT OF BODY STRUCTURE, AND THE EVENTS ARE ASSESSED AS ASSOCIATED WITH THE USE OF THE DEVICE. COMMENT: BASED ON THE INFORMATION PROVIDED, THE EVENT "BURN AND BLISTER" AS DESCRIBED IN THIS CASE IS CONSIDERED A SERIOUS BODILY INJURY REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT DAMAGE OR IMPAIRMENT OF BODY STRUCTURE, AND THE EVENTS ARE ASSESSED AS ASSOCIATED WITH THE USE OF THE DEVICE.

    Description of Event or Problem · 1

    EVENT VERBATIM [PREFERRED TERM]: VERY RED AND BLISTERS IN SEVERAL SPOTS [BLISTER], HE GOT BURNS FROM THEM ON HIS BACK [THERMAL BURN], CASE NARRATIVE: THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER. A MALE PATIENT (RETIRED DENTIST) OF AN UNSPECIFIED AGE AND ETHNICITY STARTED TO RECEIVE THERMACARE HEATWRAP (THERMACARE HEATWRAP) (DEVICE LOT NUMBER Q01103, EXPIRATION DATE JUL2019) FROM AN UNSPECIFIED DATE FOR PROBABLY 18 YEARS BEFORE FOR SCOLIOSIS AND BAD SPINE. MEDICAL HISTORY INCLUDED PAIN FROM AN UNKNOWN DATE AND UNKNOWN IF ONGOING. CONCOMITANT MEDICATION INCLUDED METAXALONE (SKELAXIN) FOR PAIN. REPORTER MENTIONED THAT HER HUSBAND USED THERMACARE QUITE FREQUENTLY, BUT THEY WERE FALLING APART. THEY SEEMED NOT TO BE MAKING THE ELASTIC PIECE THAT ADHERES. "YOU KNOW THE PIECE THAT GOES AROUND YOUR WAIST THAT SEEMS TO COME IN TWO DIFFERENT IN 1,2,3,4 PARTS. BUT IT IS COMING APART BEFORE YOU CAN EVEN GET THE FULL LAYER OUT OF IT, BEFORE THE DAY IS OVER, IT IS FALLING APART." REPORTER MENTIONED IT LOOSE THE ADHESIVENESS AND THE GRIP, WHATEVER THIS GRIP WAS. "I NOTICED THEM THEY ARE MAKING THE QUALITY IS NOT THE SAME WHICH IT WAS WHEN IT WAS ORIGINALLY CAME OUT. THESE ARE THINNER. THE LAST PIECE THAT GOES AROUND THE WAIST IS THINNER IT IS NOT AS THICK AS IT WAS." REPORTER MENTIONED THAT SHE PUT IT ON OVER HIS T-SHIRT SO THAT IT WAS NOT DIRECTLY NEXT TO HIS BODY. REPORTER MENTIONED THERE WAS NO ONE OTHER THING HER HUSBAND WORE IT TO, BUT SHE NOTICED THAT HE GOT BURNS FROM THEM ON HIS BACK. REPORTER MENTIONED THAT IT WAS NOT THE THIRD DEGREE BURN. IT WAS A VERY RED AND BLISTERS IN SEVERAL SPOTS. REPORTER TREATED HIM WITH SOME FIRST AID, TEA TREE OIL LIKE AN OINTMENT, IT CALMED DOWN BURNING AND AN AQUAPHOR TO REDUCE THE BURNING. REPORTER MENTIONED THAT HE HAD LABORATORY WORK, BUT DID NOT HAVE THE RESULTS RIGHT NOW. THE PATIENT DID NOT HAVE DIABETES, POOR CIRCULATION, HEART DISEASE AND DIFFICULTY FEELING HEAT OR PAIN ON YOUR SKIN AND RHEUMATOID ARTHRITIS AND DECREASED SENSATION AND NEUROPATHY. THE REPORTER CLASSIFIED SKIN TONE OF CONSUMER AS MEDIUM LIGHT. THE CONSUMER DID NOT HAVE SENSITIVE SKIN. THE CONSUMER DID NOT HAVE ANY ABNORMAL SKIN CONDITIONS. THE CONSUMER DID NOT SLEEP WITH IT. THE CONSUMER DID NOT ENGAGE IN EXERCISE WHILE USING THE PRODUCT. THE CONSUMER DID CHECK THE SKIN UNDER THE PRODUCT WHILE WEARING THERMACARE. THE CONSUMER HAD BEEN USING THERMACARE THAT DAY FOR APPROXIMATELY 4 OR 5 HOURS. THE CONSUMER'S DAUGHTER WAS A NURSE AND SHE KIND OF TOLD THE REPORTER WHAT TO DO. REPORTER MENTIONED THAT CONSUMER WAS STILL USING IT. THE ACTION TAKEN IN RESPONSE TO THE EVENTS FOR THERMACARE WAS DOSE NOT CHANGED. THE OUTCOME OF THE EVENTS WAS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE PROVIDED AS IT BECOMES AVAILABLE. COMPANY CLINICAL EVALUATION COMMENT BASED ON THE INFORMATION PROVIDED, THE EVENT "BURN AND BLISTER" AS DESCRIBED IN THIS CASE IS CONSIDERED A SERIOUS BODILY INJURY REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT DAMAGE OR IMPAIRMENT OF BODY STRUCTURE, AND THE EVENTS ARE ASSESSED AS ASSOCIATED WITH THE USE OF THE DEVICE. COMMENT: BASED ON THE INFORMATION PROVIDED, THE EVENT "BURN AND BLISTER" AS DESCRIBED IN THIS CASE IS CONSIDERED A SERIOUS BODILY INJURY REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT DAMAGE OR IMPAIRMENT OF BODY STRUCTURE, AND THE EVENTS ARE ASSESSED AS ASSOCIATED WITH THE USE OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193302 THERMACARE LOWER BACK & HIP DISPOSABLE PACK, HOT IMD PFIZER CONSUMER HEALTH CARE Q01103

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SKELAXIN