BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMACARE MENSTRUAL

    MDR report key: 8033488 · Received November 2, 2018

    Report

    Report Number
    1066015-2018-00135
    Event Type
    Malfunction
    Date Received
    November 2, 2018
    Report Date
    November 15, 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
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL COMPLAINT ASSESSMENT: AN EVALUATION WAS MADE BY SEARCHING FOR POSSIBLE TRENDS FOR THIS SUBCLASS REQUIRING INVESTIGATION BY THE SITE. THE FOLLOWING PCOM (PFIZER GLOBAL COMPLAINT DATABASE) SEARCH WAS PERFORMED. SCOPE: DATE CONTACTED: 20NOV2015 THROUGH 20NOV2017/MANUFACTURING SITE: PFIZER ALBANY/COMPLAINT CLASS: WRAP/PATCH/PAD/ COMPLAINT SUB CLASS: CELLS DAMAGED/LEAKING. THE PCOM SEARCH RETURNED A TOTAL OF 12 COMPLAINTS FOR MENSTRUAL PRODUCTS DURING THIS TIME PERIOD FOR THE CLASS/SUBCLASS. OF THE 12 COMPLAINTS; 5 COMPLAINTS HAVE BATCH NUMBER RECORDED AS "UNKNOWN". THE 7 REMAINING COMPLAINTS WERE EVALUATED. ONE OF THE SEVEN COMPLAINTS # WAS CONFIRMED TO HAVE A MANUFACTURING PROCESS ROOT CAUSE FOR A CELL DAMAGE/LEAKING. INVESTIGATION 1198197 WAS COMPLETED FOR COMPLAINT # DETERMINED THE ROOT CAUSE TO BE METHOD/DOCUMENT DOES NOT EXIST. THERE WAS NO MANUFACTURING WORKING INSTRUCTION (MWI) THAT EXPLAINS HOW TO PERFORM DIE-CUTTER RE-ADJUSTMENTS DURING PRODUCTION. IN ADDITION, NO PROCEDURE WAS IDENTIFIED THAT CONTAINS THE INSTRUCTION TO OPEN THE CULL STATION DURING THE DIE-CUTTER RE-ADJUSTMENTS TO ENSURE ALL PRODUCED WRAPS ARE REJECTED AND DO NOT MOVE TO THE PACKAGING PORTION OF THE MANUFACTURING LINE. COMMITMENT - (B)(4) (SOP - (B)(4) B-LINE/M-LINE - RAW MATERIAL DIE CUTTER CALIBRATION MWI) WAS CLOSED ON 28AUG2015 TO ADDRESS THE DIE CUTTER CALIBRATION PROCESS. BASED ON THIS PCOM SEARCH, THERE IS NOT A TREND IDENTIFIED FOR THE SUBCLASS OF CELL DAMAGE/LEAKING FOR MENSTRUAL PRODUCTS. ROOT CAUSE ANALYSIS / IDENTIF./ CONCLUSION: THE ROOT CAUSE FOR THIS INVESTIGATION WAS REVISED PER INVESTIGATION (B)(4) T26691, T26693, T26686 & S68516 MENSTRUAL & MUSCLE JOINT US CELLS DAMAGED/LEAKING. AND TO COMPLETE ACTION ITEM (B)(4): IDENTIFY & UPDATE ALL PREVIOUS COMPLAINT INVESTIGATIONS DUE TO UNSEALED CELLS FOR THE FOUR BATCHES. THE MARKET ACTION WAS ALSO ADDED. THE ROOT CAUSE OF THIS EVENT IS BRINE WAS PLACED OUTSIDE THE CELLS DURING MANUFACTURING DUE TO AN UNSEATED SUPPLY LI...

    Description of Event or Problem · 1

    EVENT VERBATIM [PREFERRED TERM] PRODUCT HAD LEAKED ALL INTO HER PANTS, THE BLACK STUFF, AND IT TOUCHED HER SKIN [EXPOSURE VIA SKIN CONTACT], PRODUCT HAD LEAKED ALL INTO HER PANTS, THE BLACK STUFF, AND IT TOUCHED HER SKIN [DEVICE LEAKAGE]. CASE NARRATIVE: THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER. THIS (B)(6) FEMALE CONSUMER STARTED TO RECEIVE THERMACARE HEATWRAP (THERMACARE MENSTRUAL) LOT NUMBER T26693 S, EXPIRATION DATE AUG2020, FROM (B)(6) 2017 AT 1 HEATWRAP, FIRST DAY OF CYCLE, FOR MENSTRUAL PAIN/ MENSTRUAL CRAMPING. MEDICAL HISTORY WAS NONE. CONCOMITANT MEDICATIONS WERE NONE. CONSUMER USED THE PRODUCT ALL THE TIME. SHE APPLIED THE PRODUCT TO HER STOMACH, PUT HER PANTS ON BUT THEN NOTICED THAT THE PRODUCT HAD LEAKED ALL INTO HER PANTS, THE BLACK STUFF, AND IT TOUCHED HER SKIN ON (B)(6) 2017. SHE WAS WONDERING IF SHE NEEDED TO DO ANYTHING. CONSUMER MENTIONED THAT THE PRODUCT WAS RECOMMENDED BY A FRIEND AND IT HAD CHANGED HER LIFE. SHE USED IT EVERY PERIOD AND HAD NEVER HAD A PROBLEM. SHE WAS READING ON THE BACK TO NOT USE THE PRODUCT IF IT LEAKED AND SHE JUST WANTED TO DOUBLE CHECK THAT SHE DIDN'T NEED TO DO ANYTHING. CONSUMER EXPLAINED THAT THIS JUST HAPPENED ABOUT 5 MINUTES AGO. SHE HADN'T HAD ANYTHING WEIRD HAPPEN BUT SHOULD SHE, LIKE, SCRUB HER SKIN OR SHOULD SHE NOT WORRY ABOUT IT. THE PRODUCT STATED IT WAS AIR ACTIVATE, SINGLE USE, AND DO NOT TRY AND REHEAT. SHE STOPPED THIS ONE WRAP BUT HAD ALREADY PUT ON ANOTHER WRAP. SHE WASN'T KIDDING WHEN SHE MENTIONED THEY CHANGED HER LIFE; SHE COULDN'T GET THROUGH HER PERIOD WITHOUT THEM. SHE NOTED THAT NORMALLY THE PODS WERE CENTERED BUT ONE OF THEM SEEMED DOWN MORE AND WAS RIPPED AND SHE WAS THINKING THAT MAYBE IT WAS NOT SEALED ALL THE WAY. THERE WERE 10 LITTLE HEATING PODS, AND JUST ONE WAS SPLIT OPEN AND LEAKING. SHE DID NOT NOTICE UNTIL SHE HAD ALREADY APPLIED THE PRODUCT. THE BOX AND WRAPPER WAS SEALED AND INTACT WITH NO DAMAGE NOTED. SHE WOULD SET IT ASIDE UNTIL IT HAD FINISHED HEATING UP, IT WOULD TAKE ABOUT 8 HOURS, AND THEN PUT IT AND THE WRAPPER IN A BAG. UPON FOLLOW UP ON 27DEC2017, THE PATIENT WAS NOT HOSPITALIZATION AND DID NOT RECEIVE TREATMENT DUE TO EVENTS. UPON FOLLOW UP ON 13FEB2018, SHE WAS CALLING TO CLARIFY THAT IN NO WAY DID SHE GET BURNT FROM THIS PRODUCT. SHE STATED THAT IT JUST LEAKED OUT AND SPILLED ONTO HER CLOTHES AND SKIN. SHE REPORTED IT SO THAT WE WOULD KNOW ABOUT THE SPILL AND TO ASK IF IT WAS OKAY IF THE CONTENTS THAT SPILLED WERE OKAY TO TOUCH HER SKIN. SHE HAS UPDATED HER SECOND QUESTIONNAIRE TO SHOW THAT SHE DID NOT RECEIVE ANY BURNS WITH THE PRODUCT. THE PATIENT WAS NOT HOSPITALIZED AND DID NOT RECEIVE ANY TREATMENT IN RESPONSE TO THE EVENT "PRODUCT HAD LEAKED ALL INTO HER PANTS, THE BLACK STUFF AND IT TOUCHED HER SKIN". THE ACTION TAKEN IN RESPONSE TO THE EVENTS OF THE PRODUCT WAS DOSE NOT CHANGED. THE OUTCOME OF THE EVENTS WAS RESOLVED. INVESTIGATION SUMMARY: THE ROOT CAUSE CATEGORY IS NON ASSIGNABLE (COMPLAINT NOT CONFIRMED). CONSUMER REPORTS "THE PRODUCT SEVERELY BURNED THE CONSUMER. SHE ASKS WHAT IS IN THE MATERIAL, IF THERE IS A CHEMICAL OR SOMETHING IN IT." THE CAUSE OF THE BURN IS INCONCLUSIVE SINCE REVIEW OF RECORDS DOES NOT PROVIDE EVIDENCE TO SUPPORT DEFECTIVE PRODUCT. THE PRODUCT EFFECT MAY VARY WITH EACH INDIVIDUAL. OUR MANUFACTURING OPERATIONS EMPLOY QUALITY CONTROL PROCEDURES WHICH INCLUDE IN PROCESS TESTING, AND VISUAL INSPECTION, TO ENSURE THE QUALITY OF THE PRODUCT BEING PACKAGED. THE PLANT HAS REVIEWED THIS BATCH FROM A MANUFACTURING PERSPECTIVE. NO QUALITY ISSUES WERE IDENTIFIED UPON THIS REVIEW OF BATCH RECORDS, RELEASE TESTING DATA OR, INSPECTION OF RETAINED SAMPLES. RETAINED SAMPLES MET THE PRODUCT DESCRIPTION AND THE PRODUCT IS WITHIN EXPIRATION DATE. AFTER A REVIEW OF THE BATCH THERMAL RECORDS, THERMAL RESULTS ALL MET PRODUCT RELEASE CRITERIA. THE PRODUCT QUALITY FOR THE BATCH IS NOT IMPACTED BY THIS COMPLAINT. ACCORDING TO PRODUCT QUALITY COMPLAINT GROUP INCLUDED: THE MOST PROBABLE ROOT CAUSE OF THIS EVENT IS IN THE EQUIPMENT CATEGORY, MECHANICAL FAILURE. THIS CONDITION IS SOMETHING THAT CAN HAPPEN INTERMITTENT AND DID NOT CONTINUE THROUGH THE ENTIRE PRODUCTION. IF THE CONDITION PERSISTS IN PROCESS VERIFICATIONS WILL DETECTED AND A CALIBRATION OF BRINE DOSING PUMPS (SOP - # CALIBRATION OF BRINE DOSING PUMPS, VERSION 4.0, EFFECTIVE DATE: 12SEP2017) WILL BE PERFORM. BATCH T26693 COMPLIED WITH PRODUCT RELEASE SPECIFICATION AND WILL REMAINS IN RELEASED STATUS. ACCORDING TO PRODUCT QUALITY COMPLAINT GROUP, INITIAL COMPLAINT ASSESSMENT: AN EVALUATION WAS MADE BY SEARCHING FOR POSSIBLE TRENDS FOR THIS SUBCLASS REQUIRING INVESTIGATION BY THE SITE. THE FOLLOWING PCOM (PFIZER GLOBAL COMPLAINT DATABASE) SEARCH WAS PERFORMED. SCOPE: DATE CONTACTED: 20NOV2015 THROUGH 20NOV2017/MANUFACTURING SITE: PFIZER ALBANY/COMPLAINT CLASS: WRAP/PATCH/PAD/ COMPLAINT SUB CLASS: CELLS DAMAGED/LEAKING. THE PCOM SEARCH RETURNED A TOTAL OF 12 COMPLAINTS FOR MENSTRUAL PRODUCTS DURING THIS TIME PERIOD FOR THE CLASS/SUBCLASS. OF THE 12 COMPLAINTS; 5 COMPLAINTS HAVE BATCH NUMBER RECORDED AS "UNKNOWN". THE 7 REMAINING COMPLAINTS WERE EVALUATED. ONE OF THE SEVEN COMPLAINTS # WAS CONFIRMED TO HAVE A MANUFACTURING PROCESS ROOT CAUSE FOR A CELL DAMAGE/LEAKING. INVESTIGATION (B)(4) WAS COMPLETED FOR COMPLAINT # DETERMINED THE ROOT CAUSE TO BE METHOD/DOCUMENT DOES NOT EXIST. THERE WAS NO MANUFACTURING WORKING INSTRUCTION (MWI) THAT EXPLAINS HOW TO PERFORM DIE-CUTTER RE-ADJUSTMENTS DURING PRODUCTION. IN ADDITION, NO PROCEDURE WAS IDENTIFIED THAT CONTAINS THE INSTRUCTION TO OPEN THE CULL STATION DURING THE DIE-CUTTER RE-ADJUSTMENTS TO ENSURE ALL PRODUCED WRAPS ARE REJECTED AND DO NOT MOVE TO THE PACKAGING PORTION OF THE MANUFACTURING LINE. COMMITMENT - (B)(4) (SOP - (B)(4) B-LINE/M-LINE - RAW MATERIAL DIE CUTTER CALIBRATION MWI) WAS CLOSED ON 28AUG2015 TO ADDRESS THE DIE CUTTER CALIBRATION PROCESS. BASED ON THIS PCOM SEARCH, THERE IS NOT A TREND IDENTIFIED FOR THE SUBCLASS OF CELL DAMAGE/LEAKING FOR MENSTRUAL PRODUCTS. ROOT CAUSE ANALYSIS / IDENTIF./ CONCLUSION: THE ROOT CAUSE FOR THIS INVESTIGATION WAS REVISED PER INVESTIGATION PR (B)(4) T26691, T26693, T26686 & S68516 MENSTRUAL & MUSCLE JOINT US CELLS DAMAGED/LEAKING. AND TO COMPLETE ACTION ITEM (B)(4): IDENTIFY & UPDATE ALL PREVIOUS COMPLAINT INVESTIGATIONS DUE TO UNSEALED CELLS FOR THE FOUR BATCHES. THE MARKET ACTION WAS ALSO ADDED. THE ROOT CAUSE OF THIS EVENT IS BRINE WAS PLACED OUTSIDE THE CELLS DURING MANUFACTURING DUE TO AN UNSEATED SUPPLY LINE ALLOWING AIR INTO THE SYSTEM. THIS COULD HAPPEN AFTER PURGING IF THE SUPPLY LINE FROM THE CONNECTOR TO THE DISPENSING PLATE WAS LEFT UNSEATED AS IT WAS REMOVED FROM THE BRINE PURGE BOX AND PLACED BACK ONTO THE BRINE CARRIAGE. METHOD WAS CONSIDERED AS A CONTRIBUTORY FACTOR BECAUSE AN MWI FOR PURGING BRINE IS NECESSARY. THERE IS NO DOCUMENT THAT CLEARLY PROVIDES INSTRUCTIONS ON HOW TO PURGE BRINE. THE ROOT CAUSE CATEGORY IS EQUIPMENT/OTHER WITH METHOD AS A CONTRIBUTORY FACTOR. THIS CREATED A SCENARIO WHERE A SMALL AMOUNT OF AIR COULD ENTER THE SUPPLY LINE AND THIS AIR DISCHARGED AS THE LINE RAN AT THE SLOWER STEADY STATE OF THE SLOWER VARIABLE SPEED OF 100 WRAPS PER MINUTE (WPM); THEN, THE BRINE SPUTTERED AS THE AIR BUBBLE DISCHARGED FROM THE BRINE NOZZLE, PLACING THE BRINE OUTSIDE OF THE CELL AREA. BECAUSE THE BRINE IS INJECTED SLIGHTLY FORWARD DURING SLOWER SPEEDS, THIS BRINE OUTSIDE OF THE CELL ROLLED UPSTREAM DUE TO THE MOTION OF THE PLATENS AS THEY TRAVEL FORWARD IN THE MACHINE DIRECTION. THIS LIQUID (BRINE) TRAVELED UPSTREAM, COVERING THE SURFACE OF THE BOTTOM FILM AND THE DOSED PRE MIX POWDER FOR MULTIPLE CELLS OF THE WRAP. THIS BRINE OUTSIDE OF THE CELL WAS CAPTURED BETWEEN THE HPM FILMS PREVENTING THE TOP AND BOTTOM FILM LAYERS FROM BEING BONDED BY THE SEAL ROLL. DUE TO THE PERIMETER OF THE CELL AREA NOT BEING BONDED (LAYER OF TWO FILMS), IT ALLOWED THE PRE-MIX POWDER TO FLOW OUTSIDE OF THE CELL AREA. OUR MANUFACTURING OPERATIONS EMPLOY QUALITY CONTROL PROCEDURES WHICH INCLUDE IN PROCESS TESTING, AND VISUAL INSPECTION, TO ENSURE THE QUALITY OF THE PRODUCT BEING PACKAGED. NO QUALITY ISSUES WERE IDENTIFIED UPON THIS REVIEW OF BATCH RECORDS, RELEASE TESTING DATA OR, INSPECTION OF RETAINED SAMPLES. RETAINED SAMPLES MET THE PRODUCT DESCRIPTION AND THE PRODUCT IS WITHIN EXPIRATION DATE. INVESTIGATION (B)(4) T26691, T26693, T26686 & S68516 MENSTRUAL & MUSCLE JOINT US CELLS DAMAGED/LEAKING WAS CONDUCTED FOR THE SAME SUB-CLASS. THIS BATCH T26693 WAS REVIEWED AT AQRT AND THE OUTCOME DETERMINATION WAS TO RECALL THE FOUR BATCHES (T26691, T26693, AND T26686 & S68516) PER INVESTIGATION (B)(4). FOLLOW-UP (27DEC2017): NEW INFORMATION RECEIVED FROM A CONTACTABLE CONSUMER INCLUDED: EVENT OUTCOME, THE PATIENT WAS NOT HOSPITALIZATION AND DID NOT RECEIVED TREATMENT DUE TO EVENTS, PRODUCT DETAILS (DOSAGE, ACTION TAKEN AND START DATE) AND NO CONCOMITANT MEDICATION. FOLLOW UP ATTEMPTS ARE COMPLETED. NO FURTHER INFORMATION IS EXPECTED. FOLLOW-UP (12JAN2018): NEW INFORMATION RECEIVED FROM PRODUCT QUALITY COMPLAINTS INCLUDED: PRODUCT QUALITY INVESTIGATION RESULTS, NEW EVENT BURN ADDED. FOLLOW-UP ATTEMPTS ARE COMPLETED. NO FURTHER INFORMATION IS EXPECTED. FOLLOW-UP (25JAN2018): NEW INFORMATION RECEIVED FROM PRODUCT QUALITY COMPLAINTS INCLUDED: INVESTIGATION RESULTS. FOLLOW-UP (13FEB2018, 14FEB2017 AND 14FEB2017): NEW INFORMATION RECEIVED FROM THE SAME CONTACTABLE CONSUMER TO CLARIFY THAT IN NO WAY DID SHE GET BURNT FROM THIS PRODUCT. ADDITIONAL INFORMATION RECEIVED FROM PRODUCT QUALITY COMPLAINT INCLUDES: UPDATED PRODUCT COMPLAINT INFORMATION. FOLLOW-UP (20FEB2018): NEW INFORMATION RECEIVED FROM A CONTACTABLE CONSUMER INCLUDES: DEVICE FREQUENCY AND INDICATION. THE PATIENT WAS NOT HOSPITALIZED AND DID NOT RECEIVE ANY TREATMENT IN RESPONSE TO THE EVENT "PRODUCT HAD LEAKED ALL INTO HER PANTS, THE BLACK STUFF AND IT TOUCHED HER SKIN". FOLLOW-UP ATTEMPTS ARE COMPLETED. NO FURTHER INFORMATION IS EXPECTED. FOLLOW-UP (05OCT2018 AND 30OCT2018): NEW INFORMATION RECEIVED FROM PRODUCT QUALITY COMPLAINTS INCLUDED: PRODUCT QUALITY INVESTIGATION RESULTS. FOLLOW-UP ATTEMPTS ARE COMPLETED. NO FURTHER INFORMATION IS EXPECTED. COMPANY CLINICAL EVALUATION COMMENT THE ABOVE REFERENCED LOT NUMBER T26693 WAS RECALLED ON 02OCT2018. SUBSEQUENT TO THE CONCLUSION OF A MANUFACTURING INVESTIGATION, PFIZER INITIATED A VOLUNTARY RECALL OF 6 LOTS [S68516, T26686, T26691, T26693, 8054HA, 8054HB] DUE TO A POTENTIAL FOR DEVICE LEAKAGE OF THE INGREDIENTS CONTAINED IN THE HEAT WRAP THAT COULD RESULT IN SERIOUS SKIN-RELATED EVENTS, INCLUDING BURN. THESE 6 LOTS WERE DISTRIBUTED IN THE UNITED STATES WITH EXPIRY DATES OF EITHER JULY OR AUGUST 2020. COMMENT: THE ABOVE REFERENCED LOT NUMBER T26693 WAS RECALLED ON 02OCT2018. SUBSEQUENT TO THE CONCLUSION OF A MANUFACTURING INVESTIGATION, PFIZER INITIATED A VOLUNTARY RECALL OF 6 LOTS [S68516, T26686, T26691, T26693, 8054HA, 8054HB] DUE TO A POTENTIAL FOR DEVICE LEAKAGE OF THE INGREDIENTS CONTAINED IN THE HEAT WRAP THAT COULD RESULT IN SERIOUS SKIN-RELATED EVENTS, INCLUDING BURN. THESE 6 LOTS WERE DISTRIBUTED IN THE UNITED STATES WITH EXPIRY DATES OF EITHER JULY OR AUGUST 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    872260 THERMACARE MENSTRUAL DISPOSABLE PACK, HOT IMD PFIZER CONSUMER HEALTH CARE T26693S;S68516;T26686;T26693

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR