BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACARE MENSTRUAL

    MDR report key: 8487419 · Received April 5, 2019

    Report

    Report Number
    1066015-2019-00088
    Event Type
    Injury
    Date Received
    April 5, 2019
    Date of Event
    March 1, 2019
    Report Date
    March 25, 2019
    Manufacturer
    PFIZER CONSUMER HEALTH CARE
    Product Code
    IMD
    PMA / PMN Number
    K953442
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THE ROOT CAUSE CATEGORY IS NON-ASSIGNABLE (COMPLAINT NOT CONFIRMED AS A QUALITY DEFECT). THERE WAS LIMITED DEVICE SPECIFIC INFORMATION PROVIDED, NO BATCH NUMBER OR RETURN SAMPLE WAS AVAILABLE FOR EVALUATION. WITHOUT A BATCH REFERENCE NUMBER AND/OR RETURN SAMPLE A MANUFACTURING AND TECHNICAL EVALUATION CANNOT BE COMPLETED FOR THE WRAP INVOLVED IN THIS CASE. THERE IS NOT A PRODUCT QUALITY RELATED TREND IDENTIFIED FOR THE SUBCLASS ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION. THE MANUFACTURING OPERATIONS EMPLOY QUALITY CONTROL PROCEDURES WHICH INCLUDE IN PROCESS TESTING, THERMAL TESTING AND VISUAL INSPECTION, TO ENSURE THE QUALITY OF THE PRODUCT BEING PACKAGED.

    Description of Event or Problem · 0

    EVENT VERBATIM [PREFERRED TERM] BURNED BY IT/AT FIRST IT WAS A BLISTER/WHEN THE WATER HIT IT, IT HURT, RED AND SCABBY [BURNS SECOND DEGREE] , . CASE NARRATIVE:THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER. A 27-YEAR-OLD FEMALE PATIENT (HEIGHT: 165 CM OR 5 FEET, 5 INCHES; WEIGHT: 50.8 KG OR 112 POUNDS, NOT PREGNANT) STARTED TO USE THERMACARE HEATWRAP (THERMACARE MENSTRUAL) 1 WRAP FOR 4 HOURS VIA AN UNSPECIFIED ROUTE OF ADMINISTRATION FROM MAR2019 FOR CRAMPS. MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NONE. PATIENT PREVIOUSLY USED THERMACARE HEATWRAP (THERMACARE) IN JAN OR FEB2019, AND DID NOT EXPERIENCE PROBLEM AND NEVER HAD A PROBLEM WITH THEM. THE PATIENT WAS BURNED BY IT IN (B)(6) 2019. THE PATIENT BOUGHT TWO BOXES OF THERMACARE HEATWRAPS. SHE ONLY KEPT ON FOR 4 HOURS WHICH WAS AN 8 HOUR WRAP. SHE USED THE BATHROOM WHILE WEARING THE PRODUCT BUT DID NOT NOTICE ANYTHING UNTIL LATER THAT NIGHT WHEN SHE GOT IN THE SHOWER. PATIENT GOT A VERY BAD BURN FROM WEARING IT FOR 4 HOURS WHERE THE UNDERWEAR LINE WOULD BE. IT WAS REPORTED THAT IT DID NOT LOOK LIKE A BURN, BUT WHEN THE WATER HIT IT, IT HURT. SHE HAS BEEN PUTTING NEOSPORIN ON IT. IT HAS BEEN TWO WEEKS AT THE TIME OF REPORT ((B)(6) 2019). AT FIRST IT WAS A BLISTER AND WASN'T RED, NOW IT IS RED AND SCABBY. IT LOOKED LIKE IT IS GOING TO SCAR. PATIENT IS GOING TO BUY THE BURN STUFF, IT IS GOING TO BE NOTICEABLE WHEN SHE WEARS A BATHING SUIT. PATIENT HAS NOT SEEN A DOCTOR AS OF THE TIME OF REPORT ON (B)(6) 2019, SHE WILL GO TO THE DOCTOR IN TWO WEEKS IF NOT BETTER. SHE WONDERED IF THE WRAP COULD HAVE BEEN DEFECTIVE. IT WAS ALSO REPORTED THAT SHE DID NOT EXERCISE WHILE USING THE PRODUCT, READ THE USAGE INSTRUCTIONS BEFORE USING THE PRODUCT. PATIENT DID NOT USE OTHER HEAT PRODUCTS FOR PAIN RELIEF (ELECTRIC HEATING PAD, HOT WATER BOTTLE, MICROWAVE GEL PACK). IT WAS ALSO REPORTED THAT SHE DID NOT SLEEPING WHILE WEARING THE PRODUCT, DID NOT WEAR SEVERAL LAYERS OF CLOTHING OVER THE PRODUCT, DID NOT WEAR A SNUG WAISTBAND/BELT OR SIMILAR OR OTHERWISE APPLIED PRESSURE OVER THE AREA (FOR EXAMPLE, PROLONGED CAR RIDE), AND DID NOT ATTACH THE ADHESIVE TO CLOTHING. PATIENT CLASSIFIED HER SKIN TONE AS OLIVE, DID NOT HAVE SENSITIVE SKIN, AND DID NOT HAVE ABNORMAL SKIN CONDITIONS. PATIENT THREW THE PACKAGING AWAY IN THE GARBAGE AND HAD NO INFORMATION ABOUT THE PRODUCT. THE ACTION TAKEN IN RESPONSE TO THE EVENT WITH THERMACARE HEATWRAP WAS PERMANENTLY WITHDRAWN IN (B)(6) 2019. NO INVESTIGATION WAS DONE. THERAPEUTIC MEASURES WERE TAKEN AS A RESULT OF THE EVENT. THE OUTCOME OF THE EVENT WAS NOT RECOVERED. ACCORDING TO PRODUCT QUALITY COMPLAINT GROUP: INVESTIGATION SUMMARY: THE ROOT CAUSE CATEGORY IS NON-ASSIGNABLE (COMPLAINT NOT CONFIRMED AS A QUALITY DEFECT). THERE WAS LIMITED DEVICE SPECIFIC INFORMATION PROVIDED, NO BATCH NUMBER OR RETURN SAMPLE WAS AVAILABLE FOR EVALUATION. WITHOUT A BATCH REFERENCE NUMBER AND/OR RETURN SAMPLE A MANUFACTURING AND TECHNICAL EVALUATION CANNOT BE COMPLETED FOR THE WRAP INVOLVED IN THIS CASE. THERE IS NOT A PRODUCT QUALITY RELATED TREND IDENTIFIED FOR THE SUBCLASS ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION. THE MANUFACTURING OPERATIONS EMPLOY QUALITY CONTROL PROCEDURES WHICH INCLUDE IN PROCESS TESTING, THERMAL TESTING AND VISUAL INSPECTION, TO ENSURE THE QUALITY OF THE PRODUCT BEING PACKAGED. FOLLOW-UP (24APR2019): NEW INFORMATION RECEIVED FROM A PRODUCT QUALITY COMPLAINTS GROUP INCLUDED: INVESTIGATION RESULTS. COMPANY CLINICAL EVALUATION COMMENT BASED ON THE INFORMATION PROVIDED, THE EVENT OF "BURNS SECOND DEGREE" AS DESCRIBED IS CONSIDERED SERIOUS BODILY INJURY REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT DAMAGE OR IMPAIRMENT OF BODY STRUCTURE. THE EVENT IS MEDICALLY ASSESSED AS ASSOCIATED WITH THE USE OF THE DEVICE. THERE WAS LIMITED DEVICE SPECIFIC INFORMATION PROVIDED, NO BATCH NUMBER OR RETURN SAMPLE WAS AVAILABLE FOR EVALUATION. WITHOUT A BATCH REFERENCE NUMBER AND/OR RETURN SAMPLE A MANUFACTURING AND TECHNICAL EVALUATION CANNOT BE COMPLETED FOR THE WRAP INVOLVED IN THIS CASE. PRODUCT EFFECT VARIES WITH EACH INDIVIDUAL. NO REMEDIAL ACTION/CORRECTIVE ACTION/FIELD SAFETY CORRECTIVE ACTION IS SUGGESTED AT THIS TIME., COMMENT: BASED ON THE INFORMATION PROVIDED, THE EVENT OF "BURNS SECOND DEGREE" AS DESCRIBED IS CONSIDERED SERIOUS BODILY INJURY REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT DAMAGE OR IMPAIRMENT OF BODY STRUCTURE. THE EVENT IS MEDICALLY ASSESSED AS ASSOCIATED WITH THE USE OF THE DEVICE. THERE WAS LIMITED DEVICE SPECIFIC INFORMATION PROVIDED, NO BATCH NUMBER OR RETURN SAMPLE WAS AVAILABLE FOR EVALUATION. WITHOUT A BATCH REFERENCE NUMBER AND/OR RETURN SAMPLE A MANUFACTURING AND TECHNICAL EVALUATION CANNOT BE COMPLETED FOR THE WRAP INVOLVED IN THIS CASE. PRODUCT EFFECT VARIES WITH EACH INDIVIDUAL. NO REMEDIAL ACTION/CORRECTIVE ACTION/FIELD SAFETY CORRECTIVE ACTION IS SUGGESTED AT THIS TIME.

    Description of Event or Problem · 1

    EVENT VERBATIM [PREFERRED TERM] BURNED BY IT/AT FIRST IT WAS A BLISTER/WHEN THE WATER HIT IT, IT HURT, RED AND SCABBY [BURNS SECOND DEGREE] , . CASE NARRATIVE: THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER. A (B)(6) FEMALE PATIENT ((B)(6), NOT PREGNANT) STARTED TO USE THERMACARE HEATWRAP (THERMACARE MENSTRUAL) 1 WRAP FOR 4 HOURS VIA AN UNSPECIFIED ROUTE OF ADMINISTRATION FROM (B)(6) 2019 FOR CRAMPS. MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NONE. PATIENT PREVIOUSLY USED THERMACARE HEATWRAP (THERMACARE) IN JAN OR (B)(6) 2019, AND DID NOT EXPERIENCE PROBLEM AND NEVER HAD A PROBLEM WITH THEM. THE PATIENT WAS BURNED BY IT IN (B)(6) 2019. THE PATIENT BOUGHT TWO BOXES OF THERMACARE HEATWRAPS. SHE ONLY KEPT ON FOR 4 HOURS WHICH WAS AN 8 HOUR WRAP. SHE USED THE BATHROOM WHILE WEARING THE PRODUCT BUT DID NOT NOTICE ANYTHING UNTIL LATER THAT NIGHT WHEN SHE GOT IN THE SHOWER. PATIENT GOT A VERY BAD BURN FROM WEARING IT FOR 4 HOURS WHERE THE UNDERWEAR LINE WOULD BE. IT WAS REPORTED THAT IT DID NOT LOOK LIKE A BURN, BUT WHEN THE WATER HIT IT, IT HURT. SHE HAS BEEN PUTTING NEOSPORIN ON IT. IT HAS BEEN TWO WEEKS AT THE TIME OF REPORT ((B)(6) 2019). AT FIRST IT WAS A BLISTER AND WASN'T RED, NOW IT IS RED AND SCABBY. IT LOOKED LIKE IT IS GOING TO SCAR. PATIENT IS GOING TO BUY THE BURN STUFF, IT IS GOING TO BE NOTICEABLE WHEN SHE WEARS A BATHING SUIT. PATIENT HAS NOT SEEN A DOCTOR AS OF THE TIME OF REPORT ON (B)(6) 2019, SHE WILL GO TO THE DOCTOR IN TWO WEEKS IF NOT BETTER. SHE WONDERED IF THE WRAP COULD HAVE BEEN DEFECTIVE. IT WAS ALSO REPORTED THAT SHE DID NOT EXERCISE WHILE USING THE PRODUCT, READ THE USAGE INSTRUCTIONS BEFORE USING THE PRODUCT. PATIENT DID NOT USE OTHER HEAT PRODUCTS FOR PAIN RELIEF (ELECTRIC HEATING PAD, HOT WATER BOTTLE, MICROWAVE GEL PACK). IT WAS ALSO REPORTED THAT SHE DID NOT SLEEPING WHILE WEARING THE PRODUCT, DID NOT WEAR SEVERAL LAYERS OF CLOTHING OVER THE PRODUCT, DID NOT WEAR A SNUG WAISTBAND/BELT OR SIMILAR OR OTHERWISE APPLIED PRESSURE OVER THE AREA (FOR EXAMPLE, PROLONGED CAR RIDE), AND DID NOT ATTACH THE ADHESIVE TO CLOTHING. PATIENT CLASSIFIED HER SKIN TONE AS OLIVE, DID NOT HAVE SENSITIVE SKIN, AND DID NOT HAVE ABNORMAL SKIN CONDITIONS. PATIENT THREW THE PACKAGING AWAY IN THE GARBAGE AND HAD NO INFORMATION ABOUT THE PRODUCT. THE ACTION TAKEN IN RESPONSE TO THE EVENT WITH THERMACARE HEATWRAP WAS PERMANENTLY WITHDRAWN IN (B)(6) 2019. NO INVESTIGATION WAS DONE. THERAPEUTIC MEASURES WERE TAKEN AS A RESULT OF THE EVENT. THE OUTCOME OF THE EVENT WAS NOT RECOVERED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE PROVIDED AS IT BECOMES AVAILABLE. COMPANY CLINICAL EVALUATION COMMENT: BASED ON THE INFORMATION PROVIDED, THE EVENT OF "BURNS SECOND DEGREE" AS DESCRIBED IS CONSIDERED SERIOUS BODILY INJURY REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT DAMAGE OR IMPAIRMENT OF BODY STRUCTURE. THE EVENT IS MEDICALLY ASSESSED AS ASSOCIATED WITH THE USE OF THE DEVICE., COMMENT: BASED ON THE INFORMATION PROVIDED, THE EVENT OF "BURNS SECOND DEGREE" AS DESCRIBED IS CONSIDERED SERIOUS BODILY INJURY REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT DAMAGE OR IMPAIRMENT OF BODY STRUCTURE. THE EVENT IS MEDICALLY ASSESSED AS ASSOCIATED WITH THE USE OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278955 THERMACARE MENSTRUAL DISPOSABLE PACK, HOT IMD PFIZER CONSUMER HEALTH CARE

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other| R