BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACARE LOWER BACK AND HIP

    MDR report key: 12646971 · Received October 18, 2021

    Report

    Report Number
    3007593958-2021-00040
    Event Type
    Injury
    Date Received
    October 18, 2021
    Report Date
    December 30, 2021
    Manufacturer
    ANGELINI
    Product Code
    IMD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER NARRATIVE: EXPECTED DATE OF THE NEXT REPORT 10-NOV-20221. REPORTABLE NEAR INCIDENT IDENTIFIED. INVESTIGATION IN PROGRESS. ON 15-DEC-2021, BRIDGES CONSUMER HEALTHCARE RECEIVED FOLLOW-UP INFORMATION FROM ANGELINI S.P.A. WHO OBTAINED THE INFORMATION ON 06-DEC-2021. THE REPORT VERBATIM IS AS FOLLOWS: FOLLOW-UP RECEIVED ON 06-DEC-2021 FROM QA DEPARTMENT. COMPLAINT NUMBER (B)(4). THIS INVESTIGATION WAS CONDUCTED FOR AN UNKNOWN LOT NUMBER LOWER BACK/HIP (LBH) 8-HOUR PRODUCT. LIMITED DEVICE SPECIFIC INFORMATION PROVIDED, AND NO BATCH NUMBER WAS AVAILABLE FOR EVALUATION. WITHOUT A BATCH REFERENCE NUMBER, A MANUFACTURING AND TECHNICAL EVALUATION CANNOT BE COMPLETED FOR THE WRAP INVOLVED IN THIS CASE. THE FOLLOWING COMPLAINT INTAKE, TRIAGE, AND INVESTIGATION (CITI) CUSTOMIZABLE SEARCH AND TRACKWISE DIGITAL (TWD) COMPLAINTS SEARCH PERFORMED: CITI SCOPE: DATE CONTACTED: 11/11/2018 THROUGH 03/14/2021 / MANUFACTURING SITE: PFIZER ALBANY/COMPLAINT CLASS: EXTERNAL CAUSE INVESTIGATION/COMPLAINT SUB CLASS: ADVERSE EVENT SERIOUS UNKNOWN AND ADVERSE EVENT NEGLIGIBLE MINOR. TWD SCOPE: DATE CONTACTED: 03/15/2021 THROUGH 11/11/2021 / MANUFACTURING SITE: ANGELINI ALBANY / COMPLAINT CLASS: UNDESIRABLE SIDE EFFECT / MD INCIDENT. THE CITI CUSTOMIZABLE AND TWD SEARCH RETURNED A TOTAL OF 278 COMPLAINTS FOR LOWER BACK/HIP (LBH) PRODUCTS DURING THIS PERIOD FOR THE CLASS/SUBCLASS. NONE OF THE COMPLAINTS WERE CONFIRMED TO HAVE A MANUFACTURING PROCESS ROOT CAUSE FOR A COMPLAINT OF ADVERSE EVENT SERIOUS UNKNOWN, ADVERSE EVENT NEGLIGIBLE MINOR AND MD INCIDENT. THE DATA SHOWS A SPIKE IN MAY 2019 ATTRIBUTED TO CONSUMERS REPORTING ADVERSE EVENTS AFTER BEING NOTIFIED OF A PRODUCT RECALL. CONSUMERS REFERENCED THE TOO HOT RECALL OF BATCHES S00639, S23902, S97473, AND W37940 FROM APRIL 2019. ACCORDING TO RPT-000097160, HAZARD ANALYSIS, THERMACARE HEAT WRAP PRODUCT: 8 AND 12HR, EFFECTIVE 01-JUN-2021, SECTION 10.1 MARKET ACTIONS (RECALL), IN APRIL 2019, PFIZER INITIATED A RECALL OF 4 BATCHES OF THERMACARE HEAT/WRAPS. THE BATCHES, ALL LOWER BACK, AND HIP INCLUDE S97473 (US), S00639 (GERMANY/SWITZERLAND), S23902 (UK/IRELAND), AND W37940 (GERMANY/SWITZERLAND). THE RECALL ACTION TAKEN AFTER THE BATCHES WERE RELEASED WITH AN OUT OF SPECIFICATION RESULT FOR HIGHTEMPERATURE CELL(S), AND NO PRODUCT ISOLATION OF IMPACTED PRODUCT PERFORMED. THE RELEASE OF THESE BATCHES WITHOUT PRODUCT ISOLATION IS A COMPLIANCE GAP. THE MANUFACTURING INVESTIGATION (B)(4), LEGACY QTS, CLOSED 04-SEP-2019) RESULTED IN CORRECTIVE ACTIONS, INCLUDING IMPROVING PROCEDURES FOR CONTAINING AND INVESTIGATING THE NONCONFORMING PRODUCT. BASED ON THIS CUSTOMIZABLE CITI AND TWD SEARCH, A TREND DOES NOT EXIST FOR THE SUBCLASS MD INCIDENT FOR LBH 8HR PRODUCTS. REFER TO THE 36-MONTH TRENDING CHART ATTACHMENT LOWER BACK AND HIP-MD INCIDENT (B)(6) 2018 TO (B)(6) 2021. NO FURTHER ACTION IS REQUIRED. CAPA REQUIRED: NO. BASED ON THE INFORMATION PROVIDED, THE EVENTS BURN AND DEVICE USE ERROR 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 BURN COULD BE AN ADVERSE EVENT OF THIS MEDICAL DEVICE, WHEREAS IT DOES NOT MENTION DEVICE USE ERROR 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. THE INVESTIGATION WAS CONDUCTED FOR AN UNKNOWN LOT NUMBER LOWER BACK/HIP (LBH) 8-HOUR PRODUCT. LIMITED DEVICE SPECIFIC INFORMATION PROVIDED, AND NO BATCH NUMBER WAS AVAILABLE FOR EVALUATION. WITHOUT A BATCH REFERENCE NUMBER, A MANUFACTURING AND TECHNICAL EVALUATION CANNOT BE COMPLETED FOR THE WRAP INVOLVED IN THIS CASE. A COMPLAINT INTAKE, TRIAGE, AND INVESTIGATION (CITI) CUSTOMIZABLE SEARCH AND TRACKWISE DIGITAL (TWD) COMPLAINTS SEARCH PERFORMED. BASED ON THIS CUSTOMIZABLE CITI AND TWD SEARCH, A TREND DOES NOT EXIST FOR THE SUBCLASS MD INCIDENT FOR LBH 8HR PRODUCTS. NO FURTHER ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 0

    MANUFACTURER NARRATIVE: EXPECTED DATE OF THE NEXT REPORT 10-NOV-"20221". REPORTABLE NEAR INCIDENT IDENTIFIED. INVESTIGATION IN PROGRESS.

    Description of Event or Problem · 0

    ON 04-OCT-2021, A SPONTANEOUS REPORT FROM ANGELINI S.P.A. WAS RECEIVED ON 21-SEP-2021. THE VERBATIM OF THE REPORT IS AS FOLLOWS: THIS SERIOUS SPONTANEOUS CASE, MANUFACTURER CONTROL NUMBER 2021-025689 IS AN INITIAL REPORT FROM SWITZERLAND RECEIVED ON 21-SEP-2021 FROM AN OTHER HEALTH PROFESSIONAL THROUGH VERFORA (MD21-41). THIS CASE REPORT CONCERNS A FEMALE PATIENT (AGE UNKNOWN), WHO APPLIED THERMACARE HEAT WRAPS (BATCH NUMBER AND EXPIRY DATE UNKNOWN) FOR UNKNOWN INDICATION. CONCOMITANT MEDICATIONS AND MEDICAL HISTORY WERE NOT REPORTED. ON UNKNOWN DATE, AFTER THERMACARE HEAT WRAPS INITIATION, THE PATIENT EXPERIENCED BURN, DEVICE USE ERROR. VERFORA'S MEDICAL TRAINER TRAINED A PHARMACY REGARDING THERMACARE PRODUCTS. A PHARMA ASSISTANT REPORTED THAT SOME YEARS AGO (DATE OF INCIDENT WAS POPULATED WITH (B)(6) 2021 BECAUSE THE DATE OF THE INCIDENT WAS UNKNOWN) SHE APPLIED THERMACARE HEAT WRAPS FOR THE "BACK" TWICE IN A ROW WITHOUT GIVING HER SKIN A BREAK IN BETWEEN THE TWO APPLICATIONS. SHE HAD A BURN AT THE APPLICATION SITE. SINCE THEN SHE ALWAYS TAKES A BREAK BEFORE APPLYING A SECOND PATCH AND HER SKIN SUPPORTS THE PRODUCT WELL. OUTCOME: BURN: UNKNOWN, DEVICE USE ERROR: UNKNOWN. THE ACTION TAKEN IN RESPONSE TO THE EVENT FOR THERMACARE HEAT WRAPS WAS UNKNOWN. THE CURRENT LOCATION OF THE DEVICE: UNKNOWN.

    Description of Event or Problem · 0

    ON 04-OCT-2021, A SPONTANEOUS REPORT FROM (B)(6). WAS RECEIVED ON 21-SEP-2021. THE VERBATIM OF THE REPORT IS AS FOLLOWS: THIS SERIOUS SPONTANEOUS CASE, MANUFACTURER CONTROL NUMBER (B)(4) IS AN INITIAL REPORT FROM (B)(6) RECEIVED ON 21-SEP-2021 FROM AN OTHER HEALTH PROFESSIONAL THROUGH VERFORA ((B)(4)). THIS CASE REPORT CONCERNS A FEMALE PATIENT (AGE UNKNOWN), WHO APPLIED THERMACARE HEAT WRAPS (BATCH NUMBER AND EXPIRY DATE UNKNOWN) FOR UNKNOWN INDICATION. CONCOMITANT MEDICATIONS AND MEDICAL HISTORY WERE NOT REPORTED. ON UNKNOWN DATE, AFTER THERMACARE HEAT WRAPS INITIATION, THE PATIENT EXPERIENCED BURN, DEVICE USE ERROR. VERFORA'S MEDICAL TRAINER TRAINED A PHARMACY REGARDING THERMACARE PRODUCTS. A PHARMA ASSISTANT REPORTED THAT SOME YEARS AGO (DATE OF INCIDENT WAS POPULATED WITH (B)(6) 2021 BECAUSE THE DATE OF THE INCIDENT WAS UNKNOWN) SHE APPLIED THERMACARE HEAT WRAPS FOR THE "BACK" TWICE IN A ROW WITHOUT GIVING HER SKIN A BREAK IN BETWEEN THE TWO APPLICATIONS. SHE HAD A BURN AT THE APPLICATION SITE. SINCE THEN SHE ALWAYS TAKES A BREAK BEFORE APPLYING A SECOND PATCH AND HER SKIN SUPPORTS THE PRODUCT WELL. OUTCOME: BURN: UNKNOWN, DEVICE USE ERROR: UNKNOWN. THE ACTION TAKEN IN RESPONSE TO THE EVENT FOR THERMACARE HEAT WRAPS WAS UNKNOWN. THE CURRENT LOCATION OF THE DEVICE: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1544914 THERMACARE LOWER BACK AND HIP HOT OR COLD DISPOSABLE PACK. IMD ANGELINI

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention