BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACARE HEATWRAP

    MDR report key: 12673666 · Received October 21, 2021

    Report

    Report Number
    3007593958-2021-00042
    Event Type
    Injury
    Date Received
    October 21, 2021
    Date of Event
    September 27, 2021
    Report Date
    November 12, 2021
    Manufacturer
    ANGELINI
    Product Code
    IMD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER NARRATIVE REPORTABLE NEAR INCIDENT IDENTIFIED. INVESTIGATION IN PROGRESS. THE EXPECTED DATE OF THE NEXT REPORT IS 11-NOV-2021. ON 12-NOV-2021 SAFETYCALL RECEIVED ADDITIONAL INFORMATION FROM (B)(6). WHO RECEIVED THE INFORMATION ON 07-OCT-2021. THE REPORT VERBATIM IS AS FOLLOWS: FOLLOW-UP RECEIPT ON 07-OCT-2021 FROM QA DEPARTMENT. COMPLAINT NUMBER (B)(4). BATCH CODE#: DT1857E BRAND CODE/SKU#: F00573301792W PRODUCT COUNT: 2 COUNT DATE OF MANUFACTURE: 27-APR-2020 THROUGH 01-MAY-2020 EXPIRY DATE: 2023/03 QUANTITY RELEASED: (B)(4) CARTONS BATCH DT1857E IS THE ONLY BATCH WITHIN THE SCOPE OF THIS INVESTIGATION. THERMACARE BATCHES ARE PRODUCED AS INDIVIDUAL LOTS. BATCH DT1857E WAS MANUFACTURED AS A 2-COUNT CARTON, A PORTION OF BATCH DT1857 WAS SENT TO A CONTRACTOR FOR PACKAGING INTO 2 COUNT CARTONS, THE TWO COUNT CARTON WAS LABELED BATCH DT1857E BY THE CONTRACTOR. THE DEVICE HISTORY RECORD (DHR), RESERVE SAMPLES, AND TRENDING WERE EVALUATED. NO QUALITY ISSUES WERE IDENTIFIED. BATCH DT1857E IS THE SUBLOT OF BULK PRODUCT DT1857. THE VISUAL INSPECTION CONSISTED OF RETAINED SAMPLES OF BULK PRODUCT BATCH DT1857. PER TRN-000096410, CONSUMER RETURN SAMPLES AND RETAIN EVALUATIONS, EFFECTIVE 30-JUL-2020, SECTION 8.2: INSPECTION OF RETAIN SAMPLES. THE VISUAL INSPECTION OF A RETAIN SAMPLE INCLUDED 6 POUCHED WRAPS. SAMPLE SHOWS NO OBVIOUS DEFECTS. FORM-000094632 RETAIN SAMPLE INSPECTION FORM DOCUMENTED THE RETAIN EVALUATION PERFORMED ON 25-MAR-2021 FOR AN UNRELATED COMPLAINT. AN EVALUATION OF THE COMPLAINT HISTORY CONFIRMS THAT THIS IS THE SECOND COMPLAINT FOR THE SUB CLASS ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION RECEIVED AT THE ALBANY SITE REQUIRING AN EVALUATION FOR THIS BATCH. THE COMPLAINT WAS EVALUATED TO IDENTIFY ANY POTENTIAL TREND. THE CALCULATED COMPLAINTS PER MILLION PRODUCED (CPMP) RESULT OF 38.7 WAS BELOW THE UPPER CONTROL LIMIT (UCL) OF 76.2 COMPLAINTS PER MILLION PRODUCED PER TRN-000096313, COMPLAINT TRENDING GUIDELINE, EFFECTIVE 29-APR-2021. ON THE BASIS OF THIS EVALUATION, A TREND DOES NOT EXIST FOR THIS BATCH. 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. THERMAL DATA FOR THE BATCH SHOWS ALL WRAPS MET THE REQUIRED WRAP BATCH AVERAGE TEMPERATURES (37.6 DEGREES C TO 41.6 DEGREES C) PER PAL-000095032, EFFECTIVE DATE: 03-DEC-2019. THERE WERE NO WRAP ATTRIBUTE OR VARIABLE DEFECTS RECORDED FOR THE BATCH. THIS BATCH HAS BEEN REVIEWED FROM A MANUFACTURING PERSPECTIVE. THERE ARE NO KNOWN SITE INVESTIGATIONS ASSOCIATED WITH THIS BATCH INVOLVING WRAP TEMPERATURE. OUR 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. NO QUALITY ISSUES WERE IDENTIFIED UPON THIS REVIEW OF THE BATCH DEVICE HISTORY RECORD, IN PROCESS ATTRIBUTES AND VARIABLE QUALITY CHECKS 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. ROOT CAUSE INVESTIGATION REQUIRED? NO CAPA REQUIRED? NO BASED ON THE INFORMATION PROVIDED, THE EVENT BURN BLISTER AS DESCRIBED IN THIS CASE IS CONSIDERED SERIOUS BODILY INJURY POTENTIALLY REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT DAMAGE OR IMPAIRMENT OF BODY STRUCTURE, ASSESSED AS ASSOCIATED WITH THE USE OF THE DEVICE. THE PI OF THERMACARE FLEXIBLE USE XL 8 HOUR DOES NOT MENTION THAT BURN BLISTER COULD BE AN ADVERSE EVENT OF THIS MEDICAL DEVICE. DECHALLENGE AND RECHALLENGE WERE NOT APPLICABLE. TEMPORAL ASSOCIATION ADVERSE EVENT-MEDICAL DEVICE IS PLAUSIBLE. BASED ON THE INFORMATION PROVIDED THE CAUSAL RELATIONSHIP BETWEEN THERMACARE FLEXIBLE USE XL 8 HOUR AND INCIDENT IS CONSIDERED AS POSSIBLE.

    Additional Manufacturer Narrative · 0

    MANUFACTURER NARRATIVE: REPORTABLE NEAR INCIDENT IDENTIFIED. INVESTIGATION IN PROGRESS. THE EXPECTED DATE OF THE NEXT REPORT IS 11-NOV-2021.

    Description of Event or Problem · 0

    BRIDGES CONSUMER HEALTHCARE FORWARDED THE FOLLOWING CONSUMER EMAIL TO SCI FOR DOCUMENTATION AND FOLLOW UP ON 08-OCT-2021. THE FOLLOWING EMAIL WAS RECEIVED BY BRIDGES CONSUMER HEALTHCARE ON 27-SEP-2021. THIS SERIOUS SPONTANEOUS CASE, MANUFACTURER CONTROL NUMBER 2021-025777, IS AN INITIAL REPORT FROM GERMANY RECEIVED ON 27-SEP-2021 FROM A PHARMACIST THROUGH DIAMED (DE1559). THIS CASE REPORT CONCERNS A 45-YEARS-OLD ((B)(6) 1976) FEMALE PATIENT (HEIGHT 1.61 M, WEIGHT 63 KG), WHO APPLIED THERMACARE HEAT WRAPS FOR LARGE PAIN AREAS (THERMACARE WAERMEAUFLAGEN FUER GROESSERE SCHMERZBEREICHE BATCH NUMBER DT1857E) FOR BACK PAIN. CONCOMITANT MEDICATIONS INCLUDED IBUPROFEN (TABLET) FOR PAIN TREATMENT, 600 MG IN THE MORNING AND 400 MG IN THE AFTERNOON AND PAIN OINTMENT (NOT FURTHER SPECIFIED). MEDICAL HISTORY WAS NOT REPORTED. THE PATIENT DID NOT SUFFER FROM DIABETES AND DID NOT APPLY THE PAIN OINTMENT TO TREATMENT AREA OF THERMACARE. ON (B)(6) 2021, AFTER THERMACARE HEAT WRAPS FOR LARGE PAIN AREAS INITIATION, THE PATIENT EXPERIENCED BURN BLISTER. THE PATIENT USED THE HEAT WRAP FOR ABOUT 7 HOURS AND EXPERIENCED A COMFORTABLE FEELING WITH WARMTH. AFTER REMOVING THE HEAT WRAP THE PATIENT NOTICED A BURN BLISTER IN THE SIZE OF A 5-CENT COIN. DURING APPLICATION OF THERMACARE THE PATIENT DID NOT NOTICE THE BURN BLISTER. THE SKIN DETACHED AND AFTER ABOUT ONE WEEK OF TREATMENT WITH BURN OINTMENT (GEL) (NOT FURTHER SPECIFIED) THE PATIENT RECOVERED. OUTCOME: BURN BLISTER: RECOVERED/RESOLVED. THE ACTION TAKEN IN RESPONS TO THE EVENT FOR THERMACARE HEAT WRAPS FOR LARGE PAIN AREAS WAS DRUG DISCONTINUED.

    Description of Event or Problem · 0

    BRIDGES CONSUMER HEALTHCARE FORWARDED THE FOLLOWING CONSUMER EMAIL TO SCI FOR DOCUMENTATION AND FOLLOW UP ON 08-OCT-2021. THE FOLLOWING EMAIL WAS RECEIVED BY BRIDGES CONSUMER HEALTHCARE ON 27-SEP-2021. THIS SERIOUS SPONTANEOUS CASE, MANUFACTURER CONTROL (B)(4), IS AN INITIAL REPORT FROM (B)(6) RECEIVED ON 27-SEP-2021 FROM A PHARMACIST THROUGH (B)(4). THIS CASE REPORT CONCERNS A (B)(6) FEMALE PATIENT (HEIGHT 1.61 M, (B)(6)), WHO APPLIED THERMACARE HEAT WRAPS FOR LARGE PAIN AREAS (THERMACARE BATCH NUMBER DT1857E) FOR BACK PAIN. CONCOMITANT MEDICATIONS INCLUDED IBUPROFEN (TABLET) FOR PAIN TREATMENT, 600 MG IN THE MORNING AND 400 MG IN THE AFTERNOON AND PAIN OINTMENT (NOT FURTHER SPECIFIED). MEDICAL HISTORY WAS NOT REPORTED. THE PATIENT DID NOT SUFFER FROM DIABETES AND DID NOT APPLY THE PAIN OINTMENT TO TREATMENT AREA OF THERMACARE. ON (B)(6)2021, AFTER THERMACARE HEAT WRAPS FOR LARGE PAIN AREAS INITIATION, THE PATIENT EXPERIENCED BURN BLISTER. THE PATIENT USED THE HEAT WRAP FOR ABOUT 7 HOURS AND EXPERIENCED A COMFORTABLE FEELING WITH WARMTH. AFTER REMOVING THE HEAT WRAP THE PATIENT NOTICED A BURN BLISTER IN THE SIZE OF A 5-CENT COIN. DURING APPLICATION OF THERMACARE THE PATIENT DID NOT NOTICE THE BURN BLISTER. THE SKIN DETACHED AND AFTER ABOUT ONE WEEK OF TREATMENT WITH BURN OINTMENT (GEL) (NOT FURTHER SPECIFIED) THE PATIENT RECOVERED. OUTCOME: BURN BLISTER: RECOVERED/RESOLVED. THE ACTION TAKEN IN RESPONSE TO THE EVENT FOR THERMACARE HEAT WRAPS FOR LARGE PAIN AREAS WAS DRUG DISCONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1574457 THERMACARE HEATWRAP HOT OR COLD DISPOSABLE PACK. IMD ANGELINI DT1857E

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Required Intervention IBUPROFEN 600 MG MORNING-400 MG IN AFTERNOON| IBUPROFEN 600 MG MORNING-400 MG IN AFTERNOON| UNSPECIFIED PAIN OINTMENT| UNSPECIFIED PAIN OINTMENT