BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMACARE NECK, SHOULDER & WRIST

    MDR report key: 10200814 · Received June 26, 2020

    Report

    Report Number
    1066015-2020-00135
    Event Type
    Malfunction
    Date Received
    June 26, 2020
    Report Date
    June 19, 2020
    Manufacturer
    PFIZER CONSUMER HEALTH CARE
    Product Code
    IMD
    PMA / PMN Number
    K953442
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SITE SAMPLE WAS NOT RECEIVED. SUMMARY OF INVESTIGATION: THIS INVESTIGATION WAS CONDUCTED FOR AN UNKNOWN LOT NUMBER NECK/SHOULDER/WRIST (NSW) 8HR PRODUCT. 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 WRAP/PATCH/PAD TOO HOT. LOT TREND ASSMT. & RATIONALE: A LOT TREND WAS NOT PERFORMED AS THE LOT NUMBER IS UNKNOWN.

    Description of Event or Problem · 0

    EVENT VERBATIM [PREFERRED TERM] . FEELING OF EXCESSIVE HEAT AND ANNOYING DURING MOVEMENTS [DISCOMFORT], FEELING OF EXCESSIVE HEAT AND ANNOYING DURING MOVEMENTS [DEVICE ISSUE], , NARRATIVE: THIS IS A SOLICITED REPORT FROM A NON-CONTACTABLE CONSUMER BASED ON INFORMATION RECEIVED BY PFIZER FROM (B)(4), LICENSE PARTNER FOR THERMACARE. A 42-YEARS-OLD MALE PATIENT STARTED TO RECEIVE THERMACARE HEATWRAP (THERMACARE NECK, SHOULDER & WRIST) VIA AN UNSPECIFIED ROUTE OF ADMINISTRATION FROM AN UNSPECIFIED DATE AT AN UNSPECIFIED DOSE FOR AN UNSPECIFIED INDICATION. THE PATIENT'S MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. AS PART OF A GLOBAL SURVEY COMMISSIONED BY ANGELINI PHARMA TO IPSOS FOR A MARKETING SURVEY, THE COMPANY REPORTED THE PATIENT STATED IT STAYED ON HIS NECK FOR AN HOUR, THEN HE TOOK IT OUT OF DESPERATION. HE WAS FEELING OF EXCESSIVE HEAT AND ANNOYING DURING MOVEMENTS. THE ACTION TAKEN IN RESPONSE TO THE EVENTS FOR THE PRODUCT THERMACARE HEATWRAP WAS UNKNOWN. THE OUTCOME OF THE EVENTS WAS UNKNOWN. ACCORDING TO PRODUCT QUALITY COMPLAINT GROUP: SITE SAMPLE WAS NOT RECEIVED. SEVERITY OF HARM WAS S3. SUMMARY OF INVESTIGATION: THIS INVESTIGATION WAS CONDUCTED FOR AN UNKNOWN LOT NUMBER NECK/SHOULDER/WRIST (NSW) 8HR PRODUCT. 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 WRAP/PATCH/PAD TOO HOT. LOT TREND ASSMT. & RATIONALE: A LOT TREND WAS NOT PERFORMED AS THE LOT NUMBER IS UNKNOWN. THE REPORTER'S ASSESSMENT OF THE CAUSAL RELATIONSHIP OF EVENTS WITH THE SUSPECT PRODUCT WAS NOT PROVIDED AT THE TIME OF THIS REPORT. SINCE NO DETERMINATION HAS BEEN RECEIVED, THE CASE IS MANAGED BASED ON THE COMPANY CAUSALITY ASSESSMENT. NO FOLLOW-UP ATTEMPTS NEEDED. NO FURTHER INFORMATION EXPECTED. FOLLOW-UP (05JUL2020 AND 07JUL2020): NEW INFORMATION RECEIVED FROM PRODUCT QUALITY COMPLAINT GROUP AND (B)(4), LICENSE PARTNER FOR THERMACARE INCLUDES INVESTIGATION RESULTS, REPORTER INFORMATION, BOTH EVENTS WERE DOWNGRADED TO NON-SERIOUS, CASE DOWNGRADED TO NON-REPORTABLE FOR ROW. NO FOLLOW-UP ATTEMPTS POSSIBLE. NO FURTHER INFORMATION EXPECTED.

    Description of Event or Problem · 1

    FEELING OF EXCESSIVE HEAT AND ANNOYING DURING MOVEMENTS [DEVICE ISSUE], FEELING OF EXCESSIVE HEAT AND ANNOYING DURING MOVEMENTS [DISCOMFORT]. THIS IS A SOLICITED REPORT FROM A CONTACTABLE CONSUMER BASED ON INFORMATION RECEIVED BY (B)(4), LICENSE PARTNER FOR THERMACARE. PRODUCT: THERMACARE NECK / SHOULDER / WRIST. DESCRIPTION OF ANOMALY CLAIMED: AS PART OF A GLOBAL SURVEY COMMISSIONED BY (B)(4) FOR A MARKETING SURVEY, THE ABOVE-MENTIONED COMPANY REPORTED ABOUT A (B)(6) MALE CONSUMER WHO REPORTED THE FOLLOWING : "IT STAYED ON MY NECK FOR AN HOUR, THEN I TOOK IT OUT OF DESPERATION. FEELING OF EXCESSIVE HEAT AND ANNOYING DURING MOVEMENTS". NO FOLLOW-UP ATTEMPTS NEEDED. NO FURTHER INFORMATION EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662930 THERMACARE NECK, SHOULDER & WRIST DISPOSABLE PACK, HOT IMD PFIZER CONSUMER HEALTH CARE

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention