BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMACARE LOWER BACK & HIP

    MDR report key: 10755158 · Received October 29, 2020

    Report

    Report Number
    1066015-2020-00181
    Event Type
    Malfunction
    Date Received
    October 29, 2020
    Report Date
    October 23, 2020
    Manufacturer
    PFIZER CONSUMER HEALTH CARE
    Product Code
    IMD
    UDI-DI
    00305733010020
    PMA / PMN Number
    K953442
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    EVENT VERBATIM [PREFERRED TERM]: ONE WORKED SO GOOD AND GOT SO HOT SHE WOULD SWEAT [NO ADVERSE EVENT], NARRATIVE: THIS CASE WAS MADE INVALID SINCE THERE IS NO INDICATION THE CONSUMER EXPERIENCED AN ADVERSE EVENT UNDER THERMACARE. THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER (PATIENT). A FEMALE PATIENT OF AN UNSPECIFIED AGE STARTED TO RECEIVE THERMACARE HEATWRAP (THERMACARE LOWER BACK & HIP), DEVICE LOT NUMBER AR5202, EXPIRATION DATE MAY2022, UDI NUMBER (B)(4), VIA AN UNSPECIFIED ROUTE OF ADMINISTRATION FROM AN UNSPECIFIED DATE AT UNKNOWN FREQUENCY FOR HER HIP. THE PATIENT MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PATIENT REPORTED SHE BOUGHT 8 BOX OF THE BIG ONES THAT WENT AROUND THE WAIST AND THOSE WOULD GET SO HOT THEY WOULD SWEAT. THE ONE FOR THE BACK SHE USED GOT REALLY HOT, SHE USED IT FOR HER HIP. SHE WENT ON TO EXPLAIN THAT ONE WORKED SO GOOD AND GOT SO HOT SHE WOULD SWEAT. THE ACTION TAKEN IN RESPONSE TO THE EVENTS FOR THERMACARE HEATWRAP WAS UNKNOWN. THE OUTCOME OF THE EVENTS WAS UNKNOWN. FOLLOW-UP (12NOV2020): FOLLOW-UP ATTEMPTS COMPLETED. NO FURTHER INFORMATION IS EXPECTED. AMENDMENT: THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO AMEND PREVIOUSLY REPORTED INFORMATION: CASE REASSESSED AS INVALID, DOES NOT MEET THE DEFINITION OF A MEDICAL DEVICE COMPLAINT AND WAS NOT CONSIDERED A MALFUNCTION.

    Description of Event or Problem · 1

    GETS SO HOT SHE WOULD SWEAT [HYPERHIDROSIS],THE ONE FOR THE BACK SHE USED GOT REALLY HOT; WORKS SO GOOD AND GETS SO HOT SHE WOULD SWEAT [DEVICE ISSUE]. NARRATIVE: THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER (PATIENT). A FEMALE PATIENT OF AN UNSPECIFIED AGE STARTED TO RECEIVE THERMACARE HEATWRAP (THERMACARE LOWER BACK & HIP), DEVICE LOT NUMBER AR5202, EXPIRATION DATE MAY2022, UDI NUMBER (B)(4), VIA AN UNSPECIFIED ROUTE OF ADMINISTRATION FROM AN UNSPECIFIED DATE AT UNKNOWN FREQUENCY FOR HER HIP. THE PATIENT MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PATIENT REPORTED SHE BOUGHT 8 BOX OF THE BIG ONES THAT WENT AROUND THE WAIST AND THOSE WOULD GET SO HOT THEY WOULD SWEAT. THE ONE FOR THE BACK SHE USED GOT REALLY HOT, SHE USED IT FOR HER HIP. SHE WENT ON TO EXPLAIN THAT ONE WORKED SO GOOD AND GOT SO HOT SHE WOULD SWEAT. THE ACTION TAKEN IN RESPONSE TO THE EVENTS FOR THERMACARE HEATWRAP WAS UNKNOWN. THE OUTCOME OF THE EVENTS WAS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE PROVIDED AS IT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1220102 THERMACARE LOWER BACK & HIP DISPOSABLE PACK, HOT IMD PFIZER CONSUMER HEALTH CARE AR5202 00305733010020

    Patients

    Seq Age Sex Outcome Treatment
    1