BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACARE LOWER BACK AND HIP

    MDR report key: 12661798 · Received October 19, 2021

    Report

    Report Number
    3007593958-2021-00041
    Event Type
    Injury
    Date Received
    October 19, 2021
    Date of Event
    January 19, 2021
    Report Date
    November 9, 2021
    Manufacturer
    ANGELINI
    Product Code
    IMD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER NARRATIVE: REPORTABLE NEAR INCIDENT IDENTIFIED. INVESTIGATION IN PROGRESS.

    Additional Manufacturer Narrative · 0

    ON 08-NOV-2021 BRIDGES CONSUMER HEALTHCARE RECEIVED THE FOLLOWING CASE UPDATE INFORMATION FROM ANGELINI S.P.A. ANGELINI S.P.A. RECEIVED THE INFORMATION ON 01-OCT-2021. THE REPORT VERBATIM IS AS FOLLOWS: FOLLOW-UP RECEIVED ON 01-OCT-2021 FROM QA DEPARTMENT. COMPLAINT NUMBER (B)(4). BATCH CODE#: X96240. PRODUCT COUNT: (B)(4). BRAND CODE/SKU#: F00573301009C. DATE OF MANUFACTURE: 28-OCT-2018 TO 01-NOV-2018. EXPIRY DATE: 09/2021. QUANTITY RELEASED: (B)(4). BATCH X96240 IS THE ONLY BATCH WITHIN THE SCOPE OF THIS INVESTIGATION. THERMACARE BATCHES ARE PRODUCED AS INDIVIDUAL LOTS. THE DEVICE HISTORY RECORD (DHR), RESERVE SAMPLES, AND TRENDING WERE EVALUATED. NO QUALITY ISSUES WERE IDENTIFIED. PER (B)(4), CONSUMER RETURN SAMPLES AND RETAIN EVALUATIONS, EFFECTIVE (B)(6) 2020, SECTION 8.2: INSPECTION OF RETAIN SAMPLES. THE VISUAL INSPECTION OF A RETAIN SAMPLE INCLUDED ONE CARTON AND THE FOUR POUCHED WRAPS INSIDE. THERE WERE NO OBVIOUS DEFECTS FOUND ON CARTON OR POUCHED WRAPS. FORM (B)(4). RETAIN SAMPLE INSPECTION FORM DOCUMENTED THE RETAIN EVALUATION PERFORMED ON (B)(6) 2019 FOR A NON-RELATED COMPLAINT. AN EVALUATION OF THE COMPLAINT HISTORY CONFIRMS THAT THIS IS THE SECOND COMPLAINT FOR THE SUB CLASS MD INCIDENT REQUIRING AN INVESTIGATION FOR THIS BATCH. PER (B)(4), COMPLAINT TRENDING GUIDELINES, EFFECTIVE (B)(6) 2021, A VISUAL EVALUATION WAS PERFORMED TO IDENTIFY A POTENTIAL TREND FOR THE LOT AND SUBCLASS. A TREND WAS NOT IDENTIFIED SEE ATTACHED FILE X96240 MD INCIDENT. 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 - 41.6 DEGREES C) PER (B)(4) THERMACARE AGM LOWER BACK & HIP, UNPRINTED (GUCCI, EFFECTIVE DATE: (B)(6) 2018. 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 TEMPERATURES. 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. BASED ON THE INFORMATION PROVIDED, THE EVENTS THERMAL BURN AND SKIN LESION AS DESCRIBED IN THIS CASE ARE 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 LOWER BACK AND HIP MENTION THAT THERMAL BURN COULD BE AN ADVERSE EVENT OF THIS MEDICAL DEVICE, WHEREAS IT DOES NOT MENTION SKIN LESION AS ADVERSE EVENT. DECHALLENGE AND RECHALLENGE WERE UNKNOWN. TEMPORAL ASSOCIATION ADVERSE EVENTS-MEDICAL DEVICE IS PLAUSIBLE. BASED ON THE INFORMATION PROVIDED THE CAUSAL RELATIONSHIP BETWEEN THERMACARE LOWER BACK AND HIP AND INCIDENT IS CONSIDERED AS POSSIBLE. BATCH X96240 IS THE ONLY BATCH WITHIN THE SCOPE OF THIS INVESTIGATION. THERMACARE BATCHES ARE PRODUCED AS INDIVIDUAL LOTS. THE DEVICE HISTORY RECORD (DHR), RESERVE SAMPLES, AND TRENDING WERE EVALUATED. NO QUALITY ISSUES WERE IDENTIFIED. AN EVALUATION OF THE COMPLAINT HISTORY CONFIRMS THAT THIS IS THE SECOND COMPLAINT FOR THE SUB CLASS MD INCIDENT REQUIRING AN INVESTIGATION FOR THIS BATCH. A VISUAL EVALUATION WAS PERFORMED TO IDENTIFY A POTENTIAL TREND FOR THE LOT AND SUBCLASS. 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. THIS BATCH HAS BEEN REVIEWED FROM A MANUFACTURING PERSPECTIVE. THERE ARE NO KNOWN SITE INVESTIGATIONS ASSOCIATED WITH THIS BATCH INVOLVING WRAP TEMPERATURES. 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.

    Description of Event or Problem · 0

    THE FOLLOWING CASE REPORT WAS RECEIVED BY BRIDGES CONSUMER HEALTHCARE ON 06-OCT-2021 FROM (B)(6). WHICH WAS AWARE OF THE CASE ON 23-SEP-2021. THE REPORT VERBATIM IS AS FOLLOWS: THIS SERIOUS SPONTANEOUS CASE, MANUFACTURER CONTROL NUMBER (B)(4), IS AN INITIAL REPORT FROM (B)(6) RECEIVED ON 23-SEP-2021 FROM A PHARMACIST THROUGH (B)(4). THIS CASE REPORT CONCERNS A FEMALE PATIENT ((B)(6)), WHO APPLIED THERMACARE LOWER BACK AND HIP 4 PATCHES (BATCH NUMBER X96240, EXPIRY DATE UNKNOWN) FOR UNKNOWN INDICATION. CONCOMITANT MEDICATIONS AND MEDICAL HISTORY WERE UNKNOWN. ON (B)(6) 2021, AFTER THERMACARE LOWER BACK AND HIP 4 PATCHES INITIATION, THE PATIENT EXPERIENCED THERMAL BURN, SKIN LESION. THE CUSTOMER RETURNED THE PRODUCT TO THE PHARMACY AND CLAIMED THERMAL BURNS AND SKIN LESIONS. IT IS UNKNOWN IF THE INCIDENT IS MEDICALLY CONFIRMED OR IF THE CUSTOMER RECEIVED TREATMENT. OUTCOME: THERMAL BURN: UNKNOWN, SKIN LESION: UNKNOWN. THE ACTION TAKEN IN RESPONSE TO THE EVENT FOR THERMACARE LOWER BACK AND HIP 4 PATCHES WAS UNKNOWN.

    Description of Event or Problem · 0

    THE FOLLOWING CASE REPORT WAS RECEIVED BY BRIDGES CONSUMER HEALTHCARE ON 06-OCT-2021 FROM ANGELINI S.P.A. WHICH WAS AWARE OF THE CASE ON 23-SEP-2021. THE REPORT VERBATIM IS AS FOLLOWS: THIS SERIOUS SPONTANEOUS CASE, MANUFACTURER CONTROL NUMBER (B)(4), IS AN INITIAL REPORT FROM AUSTRIA RECEIVED ON 23-SEP-2021 FROM A PHARMACIST THROUGHT ANGELINI AUSTRIA AFFILIATE ((B)(4)). THIS CASE REPORT CONCERNS A FEMALE PATIENT (30-35 YEARS), WHO APPLIED THERMACARE LOWER BACK AND HIP 4 PATCHES (BATCH NUMBER X96240, EXPIRY DATE UNKNOWN) FOR UNKNOWN INDICATION. CONCOMITANT MEDICATIONS AND MEDICAL HISTORY WERE UNKNOWN. ON (B)(6) 2021, AFTER THERMACARE LOWER BACK AND HIP 4 PATCHES INITIATION, THE PATIENT EXPERIENCED THERMAL BURN, SKIN LESION. THE CUSTOMER RETURNED THE PRODUCT TO THE PHARMACY AND CLAIMED THERMAL BURNS AND SKIN LESIONS. IT IS UNKNOWN IF THE INCIDENT IS MEDICALLY CONFIRMED OR IF THE CUSTOMER RECEIVED TREATMENT. OUTCOME: THERMAL BURN: UNKNOWN, SKIN LESION: UNKNOWN. THE ACTION TAKEN IN RESPONSE TO THE EVENT FOR THERMACARE LOWER BACK AND HIP 4 PATCHES WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1559033 THERMACARE LOWER BACK AND HIP HOT OR COLD DISPOSABLE PACK IMD ANGELINI X96240

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female Required Intervention