BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMACARE HEATWRAP

    MDR report key: 9261829 · Received October 31, 2019

    Report

    Report Number
    1066015-2019-00448
    Event Type
    Malfunction
    Date Received
    October 31, 2019
    Report Date
    May 22, 2019
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CLASS/SUB CLASS: EXTERNAL CAUSE INVESTIGATION ADVERSE EVENT SAFETY. STERILE PRODUCT: NO. SAMPLES AVAILABLE: YES, SAMPLE STATUS: NOT REQUESTED. SUMMARY OF INVESTIGATION: ROOT CAUSE OF OPEN POUCHES IS EQUIPMENT; SPECIFICALLY, ULTRASONIC SEA TECHNOLOGY IS NOT AS FORGIVING IN RELATION TO THE FOIL MATERIAL AS HEAT SEAL TECHNOLOGY (EXTERNAL MACHINE FACTORS SUCH AS PROCESS VARIABILITY AND FILM MATERIAL VARIABILITY (WAVY, WRINKLES, THICKNESS, SURLYN CONDITIONS, ETC.) AFFECT THE ABILITY TO KEEP THE REQUIRED FILM/PRODUCT ALIGNMENT AND EVEN PRESSURE OF THE ANVILS ACROSS THE SEALING AREAS THUS, COMPROMISING SEALING INTEGRITY). IN GENERAL, THE LEAK DEFECT RATE HAS REMAINED UNCHANGED DESPITE SEVERAL RELIABILITY AND ENGINEERING INITIATIVES TO IMPROVE THE SEALING PERFORMANCE. HEAT SEAL TECHNOLOGY OFFERS A MORE "FORGIVING" PROCESS TO ACCOMMODATE SOME OF THESE VARIATIONS AND STILL ACHIEVE A HERMETIC SEAL, CRITICAL TO THE FUNCTIONALITY AND LONGEVITY OF THE THERMACARE PRODUCT. THE (SITE NAME) CONSUMER SITE WILL PURCHASE AND INSTALL THREE (3) NEW HEAT SEAL FLOW WRAPPER MACHINES FOR B AND M PRODUCTION LINES. THE EXISTING BOSCH FLOW WRAPPER EQUIPMENT USED TODAY EMPLOYS ULTRASONIC SEALING TECHNOLOGY FOR BOTH, THE LONG AND CROSS SEALS OF THE THERMACARE POUCHES. THIS TECHNOLOGY HAS PROVEN TO BE UNRELIABLE, DIFFICULT TO MAINTAIN AND NOT FLEXIBLE ENOUGH TO ACCOMMODATE FOR MATERIAL VARIANCES. THE HIGHEST CONSUMER COMPLAINT FOR THE SITE IS RELATED TO POUCH SEALING DEFECTS AND THE PRODUCT NEVER WORKED DUE TO AN OPEN POUCH. THESE COMPLAINTS ARE DIRECTLY RELATED TO FAILURES DURING THE SEALING PROCESS. THE NEW MACHINES WILL UTILIZE HEAT SEAL IN THE CROSS DIRECTION OF THE FILM/POUCH TO ACHIEVE A MORE CONSISTENT HERMETIC SEAL THROUGH THE MANUFACTURING RUNS WITH THE ADDED BENEFITS OF EASIER SET UP AND OPERATION, CAPA. COMPLAINT HANDLING FOR OPEN POUCHES: COMPLAINTS RECEIVED AT THE SITE IN THE GLOBAL COMPLAINT DATABASE RELATED TO OPEN POUCH IN THE SUBCLASSES OF (BUT NOT LIMITED TO) NEVER WORKED, SQUEE

    Description of Event or Problem · 1

    EVENT VERBATIM [PREFERRED TERM] SHE WOULD GET 8 OR MORE HOURS OUT OF EACH PACK/BOXES WITH A PAD THAT DOESN'T GET HOT, OR BARELY GETS WARM [DEVICE ISSUE] , I ESPECIALLY LOVED HOW I WOULD GET 8 OR MORE HOURS OUT OF EACH PACK, HAVE THEM STAY HOT ENOUGH TO KEEP EXTREME CRAMPS AT A MINIMUM [INTENTIONAL DEVICE USE ISSUE] , DID NOT WORK [DEVICE INEFFECTIVE] , . CASE NARRATIVE: THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER. A (B)(6) FEMALE PATIENT STARTED TO RECEIVE THERMACARE HEATWRAP (THERMACARE HEATWRAP), DEVICE LOT NUMBER X17174, EXPIRATION DATE AUG2021, DEVICE LOT NUMBER AD7676, EXPIRATION DATE AUG2021 (ALSO REPORTED AS 31OCT2021), FROM 2008 TO AN UNSPECIFIED DATE, OFTEN USED 1 HEAT PACK PER 8 HOURS FOR SORE MUSCLES/MENSTRUAL CRAMPS. MOST PARTICULARLY DURING HER MENSTRUAL CYCLE IN A VERY DEMANDING FIELD OF WORK AND TO KEEP EXTREME CRAMPS AT A MINIMUM. THE PATIENT MEDICAL HISTORY WAS NOT REPORTED. NO CONCOMITANT MEDICATIONS. THE PATIENT STATED THAT SHE HAD BEEN USING HEAT PRODUCTS FOR MANY YEARS NOW, FINDING THEM TO BE SUPERIOR IN PRODUCT TO OTHER BRANDS, AND VERY USEFUL FOR HER NEEDS, MOST PARTICULARLY DURING HER MENSTRUAL CYCLE IN A VERY DEMANDING FIELD OF WORK. SHE HAD LOVED THEM AND RECOMMENDED THEM TO OTHERS. SHE ESPECIALLY LOVED HOW SHE WOULD GET 8 OR MORE HOURS OUT OF EACH PACK, HAVE THEM STAY HOT ENOUGH TO KEEP EXTREME CRAMPS AT A MINIMUM. HOWEVER, OF LATE SHE HAD BEEN FINDING BOXES WITH A PAD THAT DID NOT GET HOT, OR BARELY GOT WARM ON (B)(6) 2019. NO HOSPITALIZATION WAS INVOLVED, AND NO TREATMENT WAS PROVIDED FOR HAVE BEEN FINDING BOXES WITH A PAD THAT DOESN'T GET HOT, OR BARELY GETS WARM. THIS LAST MONTH, SHE HAD TWO BOXES WHERE EVERY SINGLE HEAT PACK IN THE BOX NEVER WARMED UP. THE LOT NUMBERS WERE (AS ON THE BACK OF THE PACKAGES): X17174 N 09/18, EXPIRATION DATE: AUG2021 00:24, AND LOT AD7676 N 11/09, EXPIRATION DATE: AUG2021 20:54. HAVING THESE HEAT PACKS NEVER GET HOT MADE THINGS INCREDIBLY DIFFICULT FOR HER JOB, AND THINGS WERE QUITE PAINFUL. SHE HAD NOT KNOWN THIS INFERIORITY FROM THE COMPANY BEFORE AND WAS QUITE SAD TO HAVE EXPERIENCED IT. IT HAD CAUSED HER TO WANT TO TRY NEW BRANDS THAT MIGHT BE MORE RELIABLE, AND CHEAPER SINCE THE COUPONS WERE NO LONGER INCLUDED IN THE BOXES. SHE WOULD LIKE TO KNOW WHAT YOU CAN DO ABOUT THE MULTIPLE HEAT PACKS AND BOXES THAT DID NOT WORK IN (B)(6) 2019. THE PATIENT REPORTED SHE DID NOT WEAR THE THERMACARE HEATWRAP FOR MORE THAN 8 HOURS IN 24H PERIOD. STATED IT WAS NOT WORKING AT ALL, OR BARELY GOT WARM. NO POINT IN WEARING IF IT NULL WORK. THE PATIENT STATED SHE DID NOT HAVE THE UNITS AS SHE THREW THEM AWAY WHEN THEY DID NOT WORK. HOWEVER, SHE DID HAVE PHOTOS OF THE BACK OF THE PACKAGES WITH THE LOT NUMBERS. THIS WAS THE FIRST TIME SHE HAD TWO WHOLE BOXES THAT DID NOT WORK. THE ACTION TAKEN IN RESPONSE TO THE EVENTS FOR THERMACARE HEATWRAP WAS UNKNOWN. THE CLINICAL OUTCOME OF THE EVENT DID NOT WORK HAS BEEN FINDING BOXES WITH A PAD THAT DOES NOT GET HOT, OR BARELY GETS WARM WAS RECOVERED IN 2019 AND REMAINING EVENTS WAS UNKNOWN. ACCORDING TO PRODUCT QUALITY COMPLAINT GROUP: CLASS/SUB CLASS: EXTERNAL CAUSE INVESTIGATION ADVERSE EVENT SAFETY. STERILE PRODUCT: NO. SAMPLES AVAILABLE: YES, SAMPLE STATUS: NOT REQUESTED. SUMMARY OF INVESTIGATION: ROOT CAUSE OF OPEN POUCHES IS EQUIPMENT; SPECIFICALLY, ULTRASONIC SEA TECHNOLOGY IS NOT AS FORGIVING IN RELATION TO THE FOIL MATERIAL AS HEAT SEAL TECHNOLOGY (EXTERNAL MACHINE FACTORS SUCH AS PROCESS VARIABILITY AND FILM MATERIAL VARIABILITY (WAVY, WRINKLES, THICKNESS, SURLYN CONDITIONS, ETC.) AFFECT THE ABILITY TO KEEP THE REQUIRED FILM/PRODUCT ALIGNMENT AND EVEN PRESSURE OF THE ANVILS ACROSS THE SEALING AREAS THUS, COMPROMISING SEALING INTEGRITY). IN GENERAL, THE LEAK DEFECT RATE HAS REMAINED UNCHANGED DESPITE SEVERAL RELIABILITY AND ENGINEERING INITIATIVES TO IMPROVE THE SEALING PERFORMANCE. HEAT SEAL TECHNOLOGY OFFERS A MORE "FORGIVING" PROCESS TO ACCOMMODATE SOME OF THESE VARIATIONS AND STILL ACHIEVE A HERMETIC SEAL, CRITICAL TO THE FUNCTIONALITY AND LONGEVITY OF THE THERMACARE PRODUCT. THE (SITE NAME) CONSUMER SITE WILL PURCHASE AND INSTALL THREE (3) NEW HEAT SEAL FLOW WRAPPER MACHINES FOR B AND M PRODUCTION LINES. THE EXISTING BOSCH FLOW WRAPPER EQUIPMENT USED TODAY EMPLOYS ULTRASONIC SEALING TECHNOLOGY FOR BOTH, THE LONG AND CROSS SEALS OF THE THERMACARE POUCHES. THIS TECHNOLOGY HAS PROVEN TO BE UNRELIABLE, DIFFICULT TO MAINTAIN AND NOT FLEXIBLE ENOUGH TO ACCOMMODATE FOR MATERIAL VARIANCES. THE HIGHEST CONSUMER COMPLAINT FOR THE SITE IS RELATED TO POUCH SEALING DEFECTS AND THE PRODUCT NEVER WORKED DUE TO AN OPEN POUCH. THESE COMPLAINTS ARE DIRECTLY RELATED TO FAILURES DURING THE SEALING PROCESS. THE NEW MACHINES WILL UTILIZE HEAT SEAL IN THE CROSS DIRECTION OF THE FILM/POUCH TO ACHIEVE A MORE CONSISTENT HERMETIC SEAL THROUGH THE MANUFACTURING RUNS WITH THE ADDED BENEFITS OF EASIER SET UP AND OPERATION, CAPA. COMPLAINT HANDLING FOR OPEN POUCHES: COMPLAINTS RECEIVED AT THE SITE IN THE GLOBAL COMPLAINT DATABASE RELATED TO OPEN POUCH IN THE SUBCLASSES OF (BUT NOT LIMITED TO) NEVER WORKED, SQUEEZE TUBE, DID NOT LAST LONG ENOUGH AND TOO COOL WILL NOT BE INVESTIGATED IN THE GLOBAL COMPLAINT DATABASE. THESE COMPLAINTS WILL BE EVALUATED IN THE GLOBAL COMPLAINT DATABASE TO ENSURE THEY ARE DUE TO "OPEN POUCH" AND THE POUCH SEALING DEFECT. NO ADDITIONAL INVESTIGATION WILL BE REQUIRED FOR THESE COMPLAINTS BASED ON THE FOLLOWING: RELEASED BATCHES MEET CRITERIA FOR POUCH LEAKS AT TIME OF RELEASE; THE SEVERITY OF POUCH LEAKS IS S1-NO HARM TO CUSTOMER; COMPLAINTS RELATED TO POUCH SEAL HAVE BEEN THOROUGHLY INVESTIGATED AND ROOT CAUSE IS WELL UNDERSTOOD; LEAK RATE FOR THE CURRENT TECHNOLOGY IS ABOUT 2000 PPM; CAPA IS IN -PLACE TO REPLACE THE ULTRASONIC SEALERS WITH HEAT SEAL TECHNOLOGY. THIS DOCUMENT WILL BE ATTACHED TO THE COMPLAINT RECORD IN THE GLOBAL DATABASE AND CLOSED WITH NO FURTHER ACTION TAKEN. SUMMARY: THE ROOT CAUSE FOR NEVER WORKED, TOO COOL, DID NOT LAST LONG ENOUGH AND SQUEEZE TUBE COMPLAINT SUB CLASSLESS IS DUE TO A POUCH (PRIMARY PACKAGING) THAT DID NOT SEAL COMPLETELY (OPEN POUCH). AN OPEN POUCH WILL EXPOSE THE WRAP TO AIR BEFORE THE CONSUMER GETS IT, CAUSING IT TO BE SPENT AND NOT HEATING UP. AN OPEN POUCH IS CAUSED BY EQUIPMENT; SPECIFICALLY, ULTRASONIC TECHNOLOGY. THE CORRECTIVE ACTION IS TO PURCHASE AND INSTALL THREE (3) NEW HEAT SEAL FLOW WRAPPER MACHINES IN BOTH PRODUCTION LINES. THE SEVERITY OF POUCH LEAKS IS S1, NO HARM TO CUSTOMER. FOLLOW UP ATTEMPTS ARE COMPLETED. NO FURTHER INFORMATION IS EXPECTED. FOLLOW-UP (24APR2019): NEW INFORMATION RECEIVED FROM A CONTACTABLE CONSUMER INCLUDED: THE SAMPLE WAS NOT AVAILABLE TO BE RETURNED. FOLLOW UP (16JUL2019): NEW INFORMATION RECEIVED FROM A CONTACTABLE CONSUMER INCLUDED PATIENT AGE: (B)(6), PRODUCT INDICATION: SORE MUSCLES/MENSTRUAL CRAMPS, PRODUCT START DATE: 2008, NO CONCOMITANT MEDICATIONS, EVENT START DATE APR-MAY2019, NO HOSPITALIZATION, NO TREATMENT, OUTCOME: DEVICE ISSUE RECOVERED. FOLLOW UP ATTEMPTS ARE COMPLETED. NO FURTHER INFORMATION IS EXPECTED. FOLLOW-UP (23AUG2019): NEW INFORMATION RECEIVED FROM PRODUCT QUALITY COMPLAINT GROUP INCLUDES INVESTIGATION RESULTS. FOLLOW UP ATTEMPTS ARE COMPLETED. NO FURTHER INFORMATION IS EXPECTED. FOLLOW-UP (22MAY2019, 03SEP2019, 05SEP2019): THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO UPGRADE THIS CASE TO A REPORTABLE MDR. NEW INFORMATION RECEIVED FROM A PRODUCT QUALITY COMPLAINT GROUP INCLUDES: SAMPLE AVAILABILITY UPDATED (FROM NO TO YES) AND STATUS, CONCLUSION. COMPANY CLINICAL EVALUATION COMMENT THE EVENT "SHE WOULD GET 8 OR MORE HOURS OUT OF EACH PACK/BOXES WITH A PAD THAT DOESN'T GET HOT, OR BARELY GETS WARM" (DEVICE ISSUE) AND (INTENTIONAL DEVICE USE ISSUE) WERE ASSESSED AS NON-SERIOUS. NO OTHER ADVERSE EVENT WAS ASSOCIATED WITH THE USE OF THE DEVICE. THIS IS A SINGLE POTENTIAL DEVICE MALFUNCTION HAS A THEORETICAL RISK TO CAUSE SKIN BURN. THE EVENT "DEVICE INEFFECTIVE" IS NON-SERIOUS. THE EVENTS WERE ASSESSED AS ASSOCIATED WITH THE USE OF THE DEVICE., COMMENT: THE EVENT "SHE WOULD GET 8 OR MORE HOURS OUT OF EACH PACK/BOXES WITH A PAD THAT DOESN'T GET HOT, OR BARELY GETS WARM" (DEVICE ISSUE) AND (INTENTIONAL DEVICE USE ISSUE) WERE ASSESSED AS NON-SERIOUS. NO OTHER ADVERSE EVENT WAS ASSOCIATED WITH THE USE OF THE DEVICE. THIS IS A SINGLE POTENTIAL DEVICE MALFUNCTION HAS A THEORETICAL RISK TO CAUSE SKIN BURN. THE EVENT "DEVICE INEFFECTIVE" IS NON-SERIOUS. THE EVENTS WERE ASSESSED AS ASSOCIATED WITH THE USE OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1053235 THERMACARE HEATWRAP DISPOSABLE PACK, HOT IMD PFIZER CONSUMER HEALTH CARE X17174; AD7676

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR