BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACARE MENSTRUAL

    MDR report key: 9260322 · Received October 31, 2019

    Report

    Report Number
    1066015-2019-00345
    Event Type
    Injury
    Date Received
    October 31, 2019
    Report Date
    May 27, 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

    INITIAL COMPLAINT ASSESSMENT: BATCH T65607 IS THE ONLY BATCH WITHIN THE SCOPE OF THIS INVESTIGATION. THERMACARE BATCHES ARE PRODUCED AS INDIVIDUAL LOTS. THE VISUAL INSPECTION OF A RETAIN SAMPLE INCLUDED FIVE CARTONS, 15 POUCHES AND THE 15 WRAPS INSIDE AND SHOWS NO OBVIOUS DEFECTS. THERE ARE NO CELLS DAMAGED OR LEAKING. FORM-46455 RETAIN SAMPLE INSPECTION FORM DOCUMENTED THE RETAIN EVALUATION PERFORMED ON 04JUN2018 FOR A RELATED COMPLAINT. AN EVALUATION OF THE COMPLAINT HISTORY CONFIRMS THAT THIS IS THE SECOND COMPLAINT FOR THE SUB CLASS CELLS DAMAGED/LEAKING FOR THIS BATCH. ON THE BASIS OF THIS EVALUATION, A TREND DOES NOT EXIST FOR THIS BATCH. 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: (B)(6) 2016 THROUGH (B)(6) 2018 MANUFACTURING SITE: (B)(4)/COMPLAINT CLASS: WRAP/PATCH/PAD/ COMPLAINT SUB CLASS: CELLS DAMAGED/LEAKING. THE PCOM SEARCH RETURNED A TOTAL OF 36 COMPLAINTS FOR MENSTRUAL PRODUCTS DURING THIS TIME PERIOD FOR THE CLASS/SUBCLASS. OF THE 36 COMPLAINTS; 11 COMPLAINTS HAVE BATCH NUMBER RECORDED AS ¿UNKNOWN¿. THE 25 REMAINING COMPLAINTS WERE EVALUATED. TWELVE OF THE 25 COMPLAINTS WERE CONFIRMED TO HAVE A MANUFACTURING RELATED ROOT CAUSE FOR THE COMPLAINT OF CELLS DAMAGED/LEAKING. #-GC, ( PR-#) A PREVIOUS INVESTIGATION FOR THE SAME COMPLAINT AND BATCH (PR-#) IDENTIFIED THE ROOT CAUSE AS METHOD/DOCUMENT DOES NOT EXIST. THERE WAS NOT A MANUFACTURING WORK INSTRUCTION (MWI) THAT EXPLAINS HOW TO PERFORM DIE-CUTTER RE-ADJUSTMENTS DURING MANUFACTURING. IN ADDITION, NO PROCEDURE WAS IDENTIFIED THAT CONTAINS THE INSTRUCTION TO OPEN THE CULL STATION DURING DIE-CUTTER RE-ADJUSTMENTS TO ENSURE ALL PRODUCED WRAPS ARE REJECTED AND DO NOT MOVE TO THE PACKAGING PORTION OF THE MANUFACTURING LINE. COMMITMENT ¿ # (SOP - # B-LINE/M-LINE - RAW MATERIAL DIE CUTTER CALIBRATION MWI) WAS CLOSED ON 28AUG2015 TO ADDRESS T.

    Description of Event or Problem · 1

    A THIRD OF THE BOTTOM BECAME UNSEALED, AND POURED OUT INTO HER TIGHTS, LEAVING BURNS ON HER HIP [THERMAL BURN], SEAL ON THE OUTSIDE DIDN'T HOLD/A FEW CRUMBS OF THE MATERIAL CAME OUT/TWO THAT I HAVE USED WERE FAULTY [DEVICE LEAKAGE]. CASE NARRATIVE: THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER. A FEMALE PATIENT OF UNSPECIFIED AGE STARTED TO RECEIVE THERMACARE HEATWRAP (THERMACARE MENSTRUAL), LOT # T65607, EXPIRATION DATE SEP2020, VIA AN UNSPECIFIED AREA OF ADMINISTRATION, FROM AN UNSPECIFIED DATE, FOR PAIN MANAGEMENT. MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PATIENT REPORTED THAT IN ONE BOX, TWO THAT SHE HAS USED WERE FAULTY. THE SEAL ON THE OUTSIDE DIDN'T HOLD. THE FIRST TIME SHE THOUGHT IT WAS A FLUKE, BECAUSE SHE HAS BEEN USING THESE FOR YEARS. A FEW CRUMBS OF THE MATERIAL CAME OUT. THE SECOND TIME, ABOUT A THIRD OF THE BOTTOM BECAME UNSEALED, AND POURED OUT INTO HER TIGHTS, LEAVING BURNS ON HER HIP. LUCKILY IT HAPPENED AT HOME SO SHE WAS ABLE TO GET THE POWDER OUT RELATIVELY QUICKLY. OBVIOUSLY, SHE HASN'T USED THE THIRD ONE FROM THE SAME BOX. SHE ALSO HAD ABOUT 6 OR 7 BOXES ON HER SHELF. IT'S DANGEROUS FOR THESE TO NOT BE PROPERLY SEALED. THE ACTION TAKEN WITH THERMACARE HEATWRAP AND THE OUTCOME OF THE EVENTS WAS UNKNOWN. ACCORDING TO THE PRODUCT QUALITY COMPLAINT GROUP: INITIAL COMPLAINT ASSESSMENT: BATCH T65607 IS THE ONLY BATCH WITHIN THE SCOPE OF THIS INVESTIGATION. THERMACARE BATCHES ARE PRODUCED AS INDIVIDUAL LOTS. THE VISUAL INSPECTION OF A RETAIN SAMPLE INCLUDED FIVE CARTONS, 15 POUCHES AND THE 15 WRAPS INSIDE AND SHOWS NO OBVIOUS DEFECTS. THERE ARE NO CELLS DAMAGED OR LEAKING. FORM-46455 RETAIN SAMPLE INSPECTION FORM DOCUMENTED THE RETAIN EVALUATION PERFORMED ON 04JUN2018 FOR A RELATED COMPLAINT. AN EVALUATION OF THE COMPLAINT HISTORY CONFIRMS THAT THIS IS THE SECOND COMPLAINT FOR THE SUB CLASS CELLS DAMAGED/LEAKING FOR THIS BATCH. ON THE BASIS OF THIS EVALUATION, A TREND DOES NOT EXIST FOR THIS BATCH. 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: (B)(6) 2016 THROUGH (B)(6) 2018, MANUFACTURING SITE: (B)(4)/COMPLAINT CLASS: WRAP/PATCH/PAD/ COMPLAINT SUB CLASS: CELLS DAMAGED/LEAKING. THE PCOM SEARCH RETURNED A TOTAL OF 36 COMPLAINTS FOR MENSTRUAL PRODUCTS DURING THIS TIME PERIOD FOR THE CLASS/SUBCLASS. OF THE 36 COMPLAINTS; 11 COMPLAINTS HAVE BATCH NUMBER RECORDED AS "UNKNOWN". THE 25 REMAINING COMPLAINTS WERE EVALUATED. TWELVE OF THE 25 COMPLAINTS WERE CONFIRMED TO HAVE A MANUFACTURING RELATED ROOT CAUSE FOR THE COMPLAINT OF CELLS DAMAGED/LEAKING. #-GC, ( PR-#) A PREVIOUS INVESTIGATION FOR THE SAME COMPLAINT AND BATCH (PR-#) IDENTIFIED THE ROOT CAUSE AS METHOD/DOCUMENT DOES NOT EXIST. THERE WAS NOT A MANUFACTURING WORK INSTRUCTION (MWI) THAT EXPLAINS HOW TO PERFORM DIE-CUTTER RE-ADJUSTMENTS DURING MANUFACTURING. IN ADDITION, NO PROCEDURE WAS IDENTIFIED THAT CONTAINS THE INSTRUCTION TO OPEN THE CULL STATION DURING DIE-CUTTER RE-ADJUSTMENTS TO ENSURE ALL PRODUCED WRAPS ARE REJECTED AND DO NOT MOVE TO THE PACKAGING PORTION OF THE MANUFACTURING LINE. COMMITMENT - # (SOP - # B-LINE/M-LINE - RAW MATERIAL DIE CUTTER CALIBRATION MWI) WAS CLOSED ON 28AUG2015 TO ADDRESS THE DIE CUTTER CALIBRATION PROCESS. #US (PR-#), #-US (PR-#) AND #-US (PR-#),#-US (PR-#), #-US (PR-#), #-US (PR-#), #-US (PR-#) AND #-US (PR-#) ARE ALL RELATED TO INVESTIGATION PR-#. PR-# DETERMINED THE MOST PROBABLE ROOT CAUSE OF THE EVENT IS IN THE EQUIPMENT CATEGORY, MECHANICAL FAILURE. THE DEFECT WAS CAUSED BY CHEMISTRY AND BRINE MIX BEING OUTSIDE OF THE CELLS; THUS, PREVENTING SEALING OF THE BOTTOM AND UPPER SHEET. THE AREA APPEARS TO HAVE BEEN LEFT UNSEALED DUE TO THE BRINE BEING IN THE AREA AROUND THE CELLS PREVENTING THEM FROM SEALING. IF THE CONDITION PERSISTS, IN-PROCESS VERIFICATIONS WOULD DETECT AND A CALIBRATION OF BRINE DOSING PUMPS (SOP- #CALIBRATION OF BRINE DOSING PUMPS, VERSION 4.0, EFFECTIVE DATE: 12SEP2017) WOULD BE PERFORMED. # (PR-#) DETERMINED THE ROOT CAUSE AS METHOD/OTHER. SOP-# "EQUIPMENT CLEANING, INSPECTION AND LUBRICATION (CIL) PROCEDURE" INCLUDES INSTRUCTIONS TO CLEAN THE LINE CRITICAL AREAS IN EACH PRODUCTION SHIFT, THE CRITICAL CILS CAN BE PERFORMED ANY TIME DURING THE EACH MANUFACTURING SHIFT. SOP-# WAS REVISED AS PART OF CONTINUOUS IMPROVEMENT, IN THE REVISION, THE CRITICAL CILS WERE HIGHLIGHTED IN YELLOW AND HAVE PRIORITY TO BE PERFORMED FIRST DURING EACH MANUFACTURING SHIFT. THIS SHOULD MITIGATE THE MISTRACKING OF THE WEB CAUSED BY THE GLUE BUILDUP ON THE HPM DEAD PLATES. 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 WERE NO WRAP ATTRIBUTE OR VARIABLE DEFECTS RECORDED FOR THE BATCH. SHIFTY TRANSITION PRODUCTION NOTES WERE REVIEWED. THERE WERE NO ISSUES NOTED THAT WOULD CAUSE A CELL DAMAGED/LEAKING COMPLAINT. THIS BATCH HAS BEEN REVIEWED FROM A MANUFACTURING PERSPECTIVE. THERE ARE NO KNOWN SITE INVESTIGATIONS ASSOCIATED WITH THIS BATCH INVOLVING CELLS DAMAGED/LEAKING DEFECTS. PRELIM. CONFIRMATION STATUS: NOT CONFIRMED. AS OF 20JUL2018, ADDITIONAL INVESTIGATION SUMMARY INCLUDED: THE ROOT CAUSE CATEGORY IS NON-ASSIGNABLE (COMPLAINT NOT CONFIRMED). THE SAMPLE HAS NOT ARRIVED AT THE SITE FROM CONSUMER FOR EVALUATION, THE COMPLAINT CAN NOT BE CONFIRMED. 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. THE PRODUCT QUALITY FOR THE BATCH IS NOT IMPACTED BY THIS COMPLAINT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE PROVIDED AS IT BECOMES AVAILABLE FOLLOW-UP (15JUN2018): NEW INFORMATION RECEIVED FROM THE PRODUCT QUALITY COMPLAINT GROUP INCLUDED INVESTIGATIONAL RESULTS. FOLLOW-UP (20JUL2018): NEW INFORMATION RECEIVED FROM THE PRODUCT QUALITY COMPLAINT GROUP INCLUDED INVESTIGATIONAL RESULTS AND PATIENT GENDER. FOLLOW-UP (14MAR2019): FOLLOW-UP ATTEMPTS ARE COMPLETED. NO FURTHER INFORMATION IS EXPECTED. FOLLOW-UP (27MAY2018): THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO UPGRADE THIS CASE TO A REPORTABLE MDR. COMPANY CLINICAL EVALUATION COMMENT: BASED ON THE INFORMATION PROVIDED, THE EVENTS THERMAL BURN AND DEVICE LEAKAGE AS DESCRIBED ARE CONSIDERED SERIOUS BODILY INJURY POTENTIALLY REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT DAMAGE OR IMPAIRMENT OF BODY STRUCTURE. THE EVENTS ARE MEDICALLY ASSESSED AS ASSOCIATED WITH THE USE OF THE DEVICE. THE REVIEW OF THE LOT/BATCH RECORDS DOES NOT SUGGEST A DEFECT OR QUALITY ISSUE RELATED TO THE MANUFACTURE OF THIS LOT. NO DEVICE MALFUNCTION HAS BEEN IDENTIFIED. NO REMEDIAL ACTION/CORRECTIVE ACTION/FIELD SAFETY CORRECTIVE ACTION IS SUGGESTED AT THIS TIME., COMMENT: BASED ON THE INFORMATION PROVIDED, THE EVENTS THERMAL BURN AND DEVICE LEAKAGE AS DESCRIBED ARE CONSIDERED SERIOUS BODILY INJURY POTENTIALLY REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT DAMAGE OR IMPAIRMENT OF BODY STRUCTURE. THE EVENTS ARE MEDICALLY ASSESSED AS ASSOCIATED WITH THE USE OF THE DEVICE. THE REVIEW OF THE LOT/BATCH RECORDS DOES NOT SUGGEST A DEFECT OR QUALITY ISSUE RELATED TO THE MANUFACTURE OF THIS LOT. NO DEVICE MALFUNCTION HAS BEEN IDENTIFIED. NO REMEDIAL ACTION/CORRECTIVE ACTION/FIELD SAFETY CORRECTIVE ACTION IS SUGGESTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1056777 THERMACARE MENSTRUAL DISPOSABLE PACK, HOT IMD PFIZER CONSUMER HEALTH CARE T65607

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention