BEUDAMED
    FDA Adverse Event Other Summary report: N

    THERMACARE LOWER BACK & HIP

    MDR report key: 4796096 · Received May 20, 2015

    Report

    Report Number
    1066015-2015-00055
    Event Type
    Other
    Date Received
    May 20, 2015
    Date of Event
    November 4, 2014
    Report Date
    November 4, 2014
    Manufacturer
    PFIZER CONSUMER HEALTH CARE
    Product Code
    IMD
    PMA / PMN Number
    K953442
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP (MAY 22, 2015). THIS CONTACTABLE CONSUMER REPORTED BY WAY OF CLAIM LETTER, MEDICAL RECORDS AND CONSUMER QUESTIONNAIRE. THIS FEMALE PATIENT APPLIED THERMACARE HEAT WRAP (THERMACARE LOWER BACK AND HIP, WRAP) OF SIZE LARGE TO EXTRA LARGE (L-XL) ONLY ONE TIME FOR 2 HOURS. THE RELEVANT MEDICAL HISTORY INCLUDED MULTI LEVEL BACK FUSION ON AN UNKNOWN DATE. IT WAS REPORTED THAT SHE CHECKED AFTER 30 MINUTES DURING USAGE OF THERMACARE HEAT WRAP AND FELT BURNING SENSATION AND TOOK IT OFF THE PRODUCT AFTER 2 HOURS DUE TO BLISTERS AND BURNS ON HER BACK. ON (B)(6) 2014, SHE WAS HOSPITALIZED FOR SMALL BLISTERS ALL OVER HER BACK, LUMBAR AREA. IN (B)(6) 2014, SHE HAD EXTREME BACK PAIN FROM BURNS AND BLISTERS. SHE HAD LEFT DERMA SCAR. IT WAS REPORTED THAT, THE BURNS AND BLISTERS WERE LAST FOR 2 WEEKS AND WERE STILL HEALING. SHE RECEIVED UNKNOWN TREATMENT FOR BURNS ON (B)(6) 2014. ON (B)(6) 2014, SHE WAS TREATED WITH BACITRACIN TOPICAL OINTMENT 120 GM TWICE DAILY FOR 7 DAYS FOR WOUND AND BURNS. AS OF MAY 22, 2015, THE CLINICAL OUTCOME OF THE EVENT EXTREME BACK PAIN WAS UNKNOWN.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP (JUNE 3, 2015). THIS CONTACTABLE CONSUMER REPORTED BY WAY OF MEDICAL RECORDS AND CONSUMER QUESTIONNAIRE. THIS FEMALE PATIENT APPLIED THERMACARE HEAT WRAP (THERMACARE LOWER BACK & HIP) DIRECTLY ONLY FOR ONE TIME TO THE SKIN OF LUMBAR/BACK FOR 30 MINUTES ON (B)(6) 2014 TO TREAT LUMBAR PAIN AND SORENESS. DURING THE USAGE OF THERMACARE HEAT WRAP, SHE CHECKED HER SKIN FOR EVERY 10 MINUTES THE RELEVANT MEDICAL HISTORY INCLUDED SCIATICA, HERNIATED AND BULGING DISC AND SPINAL STENOSIS ON AN UNKNOWN DATE, MYOCARDIAL INFARCTION IN 2013 AND BACK SURGERY IN (B)(6) 2014. THE SOCIAL HISTORY WAS SIGNIFICANT FOR TOBACCO USE ON AN UNKNOWN DATE ON (B)(6) 2014, THE PATIENT FELT BURNING SENSATION AFTER 30 MINUTES OF THERMACARE HEAT WRAP AND DEVELOPED BLISTERING OF BACK SKIN AND HAD MILD TO MODERATE PAIN. ON THE SAME DAY, SHE DISCONTINUED THE USAGE OF THERMACARE HEATWRAP ON THE SAME DATE, THE PATIENT HAD 1-2% OF BODY SURFACE AREA WITH SUPERFICIAL THICKNESS AND SOME PARTIAL THICKNESS BURNING AND SOME ERYTHEMA. IN ADDITION TO THE PREVIOUSLY REPORTED ONSET DATE OF (B)(6) 2014 FOR THE EVENT SCAR, A DIFFERENT DIAGNOSIS DATE (B)(6) 2015 WAS REPORTED. THE PATIENT WAS TREATED WITH OXYCODONE (OXYCONTIN) AND OXYCODONE FROM (B)(6) 2014 AND HYDROCODONE/ACETAMINOPHEN (NORCO) 5 MG/325 MG 1-2 TABLETS EVERY SIX HOURS AS NEEDED ORALLY FOR PAIN ON (B)(6) 2014. THE PATIENT REPORTED THAT THE CONDITION BURNS ON THE BACK THAT BLISTERED TOOK SIX MONTHS TO HEAL AND IT LEFT PERMANENT SCARS ON THE BACK. AS OF (B)(6) 2015, THE CLINICAL OUTCOME OF THE EVENT SCAR WAS NOT RECOVERED. IT WAS NOTED THAT THE PATIENT ALSO TOOK THERMACARE HEAT WRAP IN (B)(6) 2013 FOR FOUR DAYS IT WAS REPORTED THAT, THE PATIENT HAD ANOTHER THERMACARE HEAT WRAP REMAINING IN THE BOX WITH LOT NUMBER J8511 2 AND EXPIRATION DATE IN FEBRUARY 2017.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP (JUNE 9, 2015)- THIS CONTACTABLE CONSUMER REPORTED AS OF JUNE 9, 2015, THIS FEMALE PATIENT HAD BURN SCARS ON LEFT AND RIGHT SIDE OF HER BACK WHERE THE SKIN WAS MORE SEVERELY BURNED.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP (JUNE 25, 2015): THE NEW INFORMATION RECEIVED FROM COMPLAINT EVALUATION REPORT. THIS FEMALE PATIENT APPLIED THERMACARE HEAT WRAP (THERMACARE LOWER BACK & HIP) 8 HOUR 2 COUNT (CT). ON JUNE 25, 2015, THE COMPLAINT EVALUATION REPORT OF THERMACARE HEAT WRAP BATCH NUMBER J85112 EVALUATION OF ONE RETAINED SAMPLE SHOWED NO OBVIOUS DEFECTS. BATCH NUMBER J85112 WAS USED FOR INVESTIGATION FROM A MANUFACTURING AND TECHNICAL PERSPECTIVE. BATCH NUMBER J22182 WAS PACKED INTO NEW CARTONS AND CREATED BATCH NUMBER J85112. FOR THE EVALUATION, BATCH RECORDS OF THE BATCH NUMBER J22182 WERE USED ALONG WITH THE PACKING RECORDS FOR BATCH NUMBER J85112. THE REVIEW OF THE BATCH DEVICE HISTORY RECORD FOR LOT J22182 CONCLUDED ALL RELEASE REQUIREMENTS WERE MET. THE REVIEW OF THE MANUFACTURING ATTRIBUTED AND VARIABLES QUALITY CHECK ASSOCIATED WITH THE BATCH INDICATED THAT ALL REQUIRED IN PROCESS INSPECTIONS WERE PERFORMED AND ALL INSPECTION CRITERIA WERE MET. THE REVIEW OF THERMAL DATA FOR NINE DAY RUN OF BATCH J22182 SHOWED ONE INDIVIDUAL CELL TESTED ABOVE THE IN-PROCESS TEMPERATURE SPECIFICATIONS. LABORATORY INVESTIGATION REPORT (B)(4) DID NOT IDENTIFY A LABORATORY RELATED ISSUE TO EXPLAIN THE OUT OF SPECIFICATION RESULT. THE CORRECTIVE ACTION PROCEDURE REQUIRED, TEN SAMPLES RANDOMLY SELECTED FROM THE SAME HOUR OF PRODUCTION AS THE WRAP WITH THE OUT OF SPECIFICATION THERMAL RESULT. THE RESAMPLE WRAP THERMAL RESULTS DID NOT MEET THE IN-PROCESS THERMAL SPECIFICATION CRITERIA. THE HOUR OF PRODUCTION ((B)(4) CARTONS AND (B)(4) WRAPS) WAS ISOLATED AND THE PRODUCT WAS SCRAPPED. EVENT REPORT (B)(4) WAS INITIATED FOR MANUFACTURING TO INVESTIGATE THE ROOT CAUSE OF THE HOT CELL. THE (B)(4) DETERMINED METHOD/PROCEDURE WAS THE ROOT CAUSE. THE ROOT CAUSE OF THE HOT CELL WAS CONSIDERED A COMMON CAUSE DUE TO PROCESS VARIABILITY. A POUCH LEAK TESTS WERE PERFORMED FOR TOTAL OF (B)(4) PACKAGING TECHNOLOGIES AND INSPECTION (PTI) WITH (B)(4) FAILURES. POUCH LEAK MAXIMUM ACCEPTANCE LIMIT FOR A BATCH SIZE OF (B)(4) PT WAS (B)(4) FAILURES. THERE WERE NO WRAP VARIABLE DEFECTS RECORDED FOR THE BATCH. THERE WERE "(B)(4)" WRAP ATTRIBUTE DEFECTS RECORDED WHICH WERE MAJOR WRAP DELAMINATION, TEARS AND DEAD CELL (AN INDIVIDUAL CELL THAT WAS NOT DOSED WITH BRINE). THE CONCLUSION OF THE REPORT INCLUDED NO QUALITY ISSUES, THERMAL TEST DATA, INSPECTION OF RETAINED SAMPLES. RETAINED SAMPLES MET THE PRODUCT DESCRIPTION AND THE PRODUCT WAS WITHIN EXPIRATION DATE. ALL PROCEDURES WERE FOLLOWED AND ALL CRITERIA MET, HOWEVER THE POSSIBILITY OF THIS DEFECT OCCURRING WAS STILL PRESENT. IT WAS REPORTED THAT, THERE WAS NO OTHER OUT OF SPECIFICATION TEMPERATURE EVENTS ASSOCIATED WITH THE BATCH OVER THE 9 DAY PRODUCTION RUN AND THERE WAS NO WAY TO DETERMINE IF THE TEMPERATURE OF THE ACTUAL WRAP USED BY THE CUSTOMER WAS OUTSIDE THE THERMAL TEMPERATURE IN-PROCESS SPECIFICATION. ROOT CAUSE WAS CATEGORIZED AS NON-ASSIGNABLE (COMPLAINT NOT CONFIRMED), NO QUALITY IMPACT, MARKET/CLINICAL IMPACT, STABILITY IMPACT. THE FINAL CONFIRMATION STATUS WAS NOT CONFIRMED.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP (25 NOV 2014): NEW INFORMATION RECEIVED FROM A CONTACTABLE CONSUMER INCLUDES: ACTION TAKEN WITH SUSPECT PRODUCT, PRODUCT STOP DATE, EVENT ONSET DATE, UPDATED LOT NUMBER AND EXPIRATION DATE, CONCOMITANT MEDICATIONS, EVENT OUTCOME AND ADDITIONAL EVENTS OF SCAR AND DEVICE MISUSE. FOLLOW UP (13 APR 2015): NEW INFORMATION RECEIVED FROM A NON-CLINICAL-STUDY PROGRAM INCLUDES: MARKETING PROGRAM INFORMATION. FOLLOW UP ATTEMPTS COMPLETED. NO FURTHER INFORMATION EXPECTED. FOLLOW-UP (12 MAY 2015): NEW INFORMATION RECEIVED FROM A CONTACTABLE CONSUMER INCLUDES: UPDATED EVENTS BURN AND BLISTERS TO 2ND DEGREE BURNS. THIS CASE IS REPORTABLE AS A SERIOUS, MEDICAL DEVICE REPORT. COMPANY CLINICAL EVALUATION COMMENT BASED ON THE INFORMATION PROVIDED, THE EVENTS BURN SECOND DEGREE AND SCAR AS DESCRIBED IN THIS CASE IS CONSIDERED A SERIOUS BODILY INJURY POTENTIALLY REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT DAMAGE OR IMPAIRMENT OF BODY STRUCTURE, ASSESSED AS ASSOCIATED WITH THE USE OF THE DEVICE. DEVICE MISUSE IS CONSIDERED AS ASSOCIATED WITH DEVICE USE. THIS CASE MEETS INITIAL 10-DAY EU AND 30-DAY FDA REPORTABILITY.

    Description of Event or Problem · 1

    EXTREME BACK PAIN [BACK PAIN].

    Description of Event or Problem · 1

    FELT BURNING SENSATIONS, BURN BLISTER, MADE SMALL BLISTERS ALL OVER HER BACK, LUMBAR AREA [BURNS SECOND DEGREE], USING HEATWRAP FOR BACK PAIN FOLLOWING BACK SURGERY [DEVICE MISUSE], HORRIBLE PERMANENT SCARS FORMING [SCAR]. CASE DESCRIPTION: THIS IS A SPONTANEOUS REPORT FROM A NON-CLINICAL-STUDY PROGRAM, (B)(6). A CONTACTABLE CONSUMER REPORTED A (B)(6) HISPANIC FEMALE PATIENT STARTED RECEIVING THERMACARE HEATWRAP (THERMACARE LOWER BACK AND HIP) (LOT#: J22182, EXPIRATION DATE: FEB2017) ON (B)(6) 2014 BETWEEN 6AM AND 8AM FOR BACK PAIN FOLLOWING BACK SURGERY. MEDICAL HISTORY INCLUDED BACK PAIN FOR APPROXIMATELY 10 YEARS AND ONGOING AND SPINAL FUSION SURGERY (MID-LEVEL) ON AN UNSPECIFIED DATE IN 2014 (REPORTED AS ABOUT 2.5 MONTHS AGO AND UNDER THE CARE OF A PHYSICIAN). THE CONSUMER'S CONCOMITANT MEDICATIONS INCLUDED OXYCODONE 20 MG 4 TIMES DAILY FOR BACK PAIN AND OXYCONTIN 40 MG 2 TIMES DAILY FOR BACK PAIN. THE CONSUMER PREVIOUSLY USED THERMACARE HEATWRAPS FROM (B)(6) 2000, USED TO WEAR IT CONSTANTLY FOR BACK PAIN. THEY WORKED SO GOOD. THE PATIENT USED A FULL BODY LENGTH HEAT MASSAGER THAT BURNED OUT ON HER 1.5 MONTHS AGO. THE PATIENT REPORTED USING THE PRODUCT ON THE MORNING OF (B)(6) 2014 AT APPROXIMATELY 6:00A.M. SHE PLACED THE HEATWRAP ON AND APPROXIMATELY 2 HOURS LATER SHE FELT BURNING. THE CONSUMER STATED SHE CHECKED UNDER THE WRAP AND NOTED BURNS AND BLISTERS HAD BEGUN TO APPEAR ALL OVER HER BACK, LUMBAR AREA. THE PATIENT REPORTED GOING TO THE EMERGENCY ROOM ON (B)(6) 2014 FOR 2ND DEGREE BURNS. THERAPEUTIC MEASURES INCLUDED UNSPECIFIED PAIN MEDICATIONS AND ANTIBIOTIC CREAMS. IT WAS REPORTED, 2 WEEKS AFTER THE BURN BLISTERS SHE NOW HAS HORRIBLE PERMANENT SCARS FORMING. THE PATIENT STATED SHE WONDERED IF THE WRAPS WERE DEFECTIVE BECAUSE SHE HAS NEVER EXPERIENCED THIS BEFORE AND HAD USED THE PRODUCT BEFORE IN THE PAST. ACTION TAKEN WITH THE SUSPECT PRODUCT WAS PERMANENTLY WITHDRAWN ON AN (B)(6) 2014. CLINICAL OUTCOME OF THE EVENTS WAS RESOLVING WITH SEQUELAE. THE PATIENT HAD NO DIABETES, NO POOR CIRCULATION, NO HEART DISEASE, NO DIFFICULTY FEELING HEAT OR PAIN ON SKIN, NO RHEUMATOID ARTHRITIS AND NO DECREASED SENSATION. SHE HAS MEDIUM SKIN TONE, NO SENSITIVE SKIN AND NO ABNORMAL SKIN CONDITIONS. THE PATIENT MENTIONED SHE DID NOT SLEEP WHILE WEARING THE PRODUCT, WAS NOT WEARING SEVERAL LAYERS OF CLOTHING OVER THE PRODUCT, APPLIED NO PRESSURE OVER THE AREA AND DID NOT EXERCISE WHILE USING THE PRODUCT. SHE MENTIONED SHE READ THE INSTRUCTIONS BEFORE USE AND HAD NOT APPLIED ANY MEDICATIONS TO THE SKIN. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE PROVIDED AS IT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329161 THERMACARE LOWER BACK & HIP DISPOSABLE PACK, HOT IMD PFIZER CONSUMER HEALTH CARE J22182

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention