BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMACARE MENSTRUAL

    MDR report key: 8032889 · Received November 2, 2018

    Report

    Report Number
    1066015-2018-00131
    Event Type
    Malfunction
    Date Received
    November 2, 2018
    Report Date
    October 9, 2018
    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

    THE ROOT CAUSE AND CAPA FOR THE CONFIRMED COMPLAINTS THAT WERE RELATED TO THE BRINE OUTSIDE OF THE CELLS ARE AS FOLLOWS: (B)(4) ARE RELATED TO INVESTIGATION (B)(4), BATCH T26691 MANUFACTURED 29AUG2017. (B)(4) DETERMINED THE MOST PROBABLE ROOT CAUSE OF THE EVENT IS IN THE EQUIPMENT, OTHER. 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. (B)(4) ARE ALL RELATED TO INVESTIGATION (B)(4), BATCH T26693 MANUFACTURED 27SEP2017. (B)(4) DETERMINED THE MOST PROBABLE ROOT CAUSE OF THE EVENT IS IN THE EQUIPMENT, OTHER. 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 PUR.

    Description of Event or Problem · 1

    EVENT VERBATIM [PREFERRED TERM] ITCHINESS [PRURITUS], REDNESS [ERYTHEMA], ERUPTED AND LEAKED BLACK POWDER/POWDER TOUCHED HER SKIN [ACCIDENTAL EXPOSURE TO PRODUCT], HAD ONE THAT ERUPTED AND LEAKED BLACK POWDER [DEVICE LEAKAGE]. CASE NARRATIVE: THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER. A (B)(6) FEMALE PATIENT STARTED TO RECEIVE THERMACARE HEATWRAP (THERMACARE MENSTRUAL), DEVICE LOT NUMBER T26691, EXPIRATION DATE JUL2020, FROM AN UNSPECIFIED DATE AT UNKNOWN FREQUENCY FOR PAIN MENSTRUAL. MEDICAL HISTORY WAS NONE. THERE WERE NO CONCOMITANT MEDICATIONS. THE PATIENT STATED SHE SAW THERE WAS A RECALL ON THERMACARE HEATWRAPS ADVANCED MENSTRUAL PAIN THERAPY. SHE HAD ONE THAT ERUPTED AND LEAKED BLACK POWDER ON (B)(6) 2018. SHE DIDN'T NOTICE IT UNTIL SHE WENT TO THE BATHROOM AND SAW THE BLACK POWDER. IT MADE HER ITCHY ON (B)(6) 2018. SHE EXPERIENCED NOTHING OTHER THAN ITCHINESS AND A LITTLE REDNESS ON (B)(6) 2018. SHE WANTED TO KNOW IF THERE WAS ANYTHING ELSE SHE NEEDED TO DO SINCE THE POWDER TOUCHED HER SKIN. SHE STATED SHE WAS USING THE THERMACARE HEATWRAPS ADVANCED MENSTRUAL PAIN THERAPY. ONE HEATWRAP LEAKED OUT OF THE THREE THAT WERE IN THE BOX. SHE THREW IT IN HER TRASH AT WORK. SHE MIGHT BE ABLE TO RETRIEVE IT IF THEY DID NOT TAKE THE TRASH OUT OVERNIGHT. THE ACTION TAKEN IN RESPONSE TO THE EVENTS WAS UNKNOWN. THE OUTCOME OF THE EVENTS WAS RECOVERING. CONCLUSION FROM THE PRODUCT QUALITY COMPLAINT GROUP INCLUDED: THE ROOT CAUSE AND CAPA FOR THE CONFIRMED COMPLAINTS THAT WERE RELATED TO THE BRINE OUTSIDE OF THE CELLS ARE AS FOLLOWS: (B)(4) ARE RELATED TO INVESTIGATION (B)(4), BATCH T26691 MANUFACTURED 29AUG2017. (B)(4) DETERMINED THE MOST PROBABLE ROOT CAUSE OF THE EVENT IS IN THE EQUIPMENT, OTHER. 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. (B)(4) ARE ALL RELATED TO INVESTIGATION (B)(4), BATCH T26693 MANUFACTURED 27SEP2017. (B)(4) DETERMINED THE MOST PROBABLE ROOT CAUSE OF THE EVENT IS IN THE EQUIPMENT, OTHER. 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. (B)(4) BATCH T65607 MANUFACTURED 22-OCT-2017 TO 26-OCT-2017. (B)(4) DETERMINED THE MOST PROBABLE ROOT CAUSE AS EQUIPMENT. THE DEFECT WAS CAUSED BY BRINE BEING OUTSIDE OF THE CELLS; THUS, PREVENTING SEALING OF THE BOTTOM AND UPPER SHEET. ON (B)(6) 2017 DAY SHIFT, BRINE PUMP A40 WAS CHANGED. THIS PUMP CORRELATES TO THE DAMAGED / LEAKING CELLS ON THE CONSUMER RETURNED SAMPLE. HOWEVER, THIS IS NOT RELATED TO THE BRINE OUTSIDE OF THE CELLS BECAUSE A FAILED BRINE PUMP WILL NOT PUMP BRINE; THEREFORE, THE CELL WOULD BE DEAD (NOT HEAT-UP) DUE TO THE ABSENCE OF BRINE (NO BRINE AT ALL). TYPICALLY AIR IN THE LINE WILL PLACE BRINE OUTSIDE OF THE CELLS BETWEEN THE TWO LAYERS OF FILM OF THE CELL PACK WHEN IT DISCHARGES (SPURTS) FROM THE BRINE NOZZLE. PURGE IS A PROCEDURE TO REMOVE THE AIR IN THE LINES. THERMACARE PRODUCTS MANUFACTURING MAKING INSTRUCTION REQUIRE THAT IF THE LINE IS DOWN MORE THAN 2 HOURS PURGE FOR FIVE MINUTES AND IF THE LINE IS DOWN FOR MORE THAN 8 HOURS PURGE FOR FIFTEEN MINUTES. HOWEVER, THERE IS NO PROCEDURE PROVIDING INSTRUCTIONS TO PURGE THE BRINE LINES AFTER A PUMP IS CHANGED. COMMITMENT (B)(4) TO CREATE A VISUAL AID TO REQUIRE OPERATORS TO PURGE THE BRINE LINES AND VERIFY THE AIR IS NOT WITHIN THE LINES EVERY TIME THAT A BRINE PUMP IS REPLACED OR CALIBRATED. REVIEW OF THE BATCH DEVICE HISTORY RECORD FOR THIS BATCH CONCLUDES ALL RELEASE REQUIREMENTS WERE MET. THE REVIEW OF THE MANUFACTURING ATTRIBUTES AND VARIABLES QUALITY CHECKS ASSOCIATED WITH THIS BATCH INDICATES THAT ALL REQUIRED IN PROCESS INSPECTIONS WERE PERFORMED AND ALL INSPECTION CRITERIA WERE MET. THERE WAS ONE WRAP ATTRIBUTE DEFECT RECORDED FOR THE BATCH, GLUE BLOB/DRIPS - MINOR, A GLUE NOZZLE WAS CHANGED TO CORRECT THE DEFECT. THE CORRECTIVE ACTION PROCEDURES WERE FOLLOWED PER STANDARD OPERATING PROCEDURE (B)(4)-PRODUCT QUALITY CONTROL CAP PROCEDURE, EFFECTIVE DATE: 14DEC2015. THERE WERE NO WRAP VARIABLE DEFECTS RECORDED FOR THE BATCH. SHIFTLY PRODUCTION TRANSITION NOTES WERE REVIEWED. ON (B)(6) 2017-THERE WERE ISSUES WITH STRAY CHEMISTRY AND RECYCLE BLADE POSITION ERROR FAULTS. IT WAS FOUND, ONE OF THE FILL TUBES FOR THE DOSING BELT WAS COMING OFF. A NEW DOSING BELT AND RECYCLE BLADE WAS INSTALLED, THIS RESOLVED THE ISSUES. IT WAS NOTED ON (B)(6) 2017 THERE WERE ISSUES WITH THE DIE CUTTER OPENING, CAUSED BY THE HEAT PACK MAKER TOP AND BOTTOM SHEET POLY DRAGGING, LOOSE AND MISTRACKING AT THE DIE INFEED CONVEYOR CAUSING ISSUES WITH THE DIE CUTTING. THE DRAW WAS CHANGED ON THE HEAT PACK MAKER DISCHARGE CONVEYOR FROM 100.4 TO 100.0, THIS RESOLVED THE WEB DRAGGING AND MISTRACKING. NEITHER OF THESE ISSUES WOULD CAUSE THE DEFECT SEEN ON THE RETURNED WRAP WITH LEAKAGE. THIS BATCH HAS BEEN REVIEWED FROM A MANUFACTURING PERSPECTIVE. THERE ARE NO KNOWN INVESTIGATIONS FOR THIS BATCH AT THE TIME OF RELEASE. COMPANY CLINICAL EVALUATION COMMENT: THE ABOVE REFERENCED LOT NUMBER T26691 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 T26691 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
    872252 THERMACARE MENSTRUAL DISPOSABLE PACK, HOT IMD PFIZER CONSUMER HEALTH CARE T26691

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR