BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMACARE LOWER BACK & HIP

    MDR report key: 11401505 · Received March 2, 2021

    Report

    Report Number
    1066015-2021-00025
    Event Type
    Malfunction
    Date Received
    March 2, 2021
    Report Date
    February 9, 2021
    Manufacturer
    PFIZER CONSUMER HEALTH CARE
    Product Code
    IMD
    PMA / PMN Number
    K953442
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    EVENT VERBATIM [PREFERRED TERM]. HAD THE HEAT CELLS OPEN [DEVICE LEAKAGE], , NARRATIVE: THIS CASE IS INVALID DUE TO BEING THE NON-RETAINED DUPLICATE OF AER# 2021161030. THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER (PATIENT). THIS CONSUMER REPORTED TWO DEVICES. THIS IS THE SECOND OF 2 REPORTS. A PATIENT OF UNSPECIFIED AGE AND GENDER STARTED TO RECEIVE THERMACARE HEATWRAP (THERMACARE LOWER BACK & HIP), DEVICE LOT NUMBER BK2631, EXPIRATION DATE JAN2023, VIA AN UNSPECIFIED ROUTE OF ADMINISTRATION FROM AN UNSPECIFIED DATE AT AN UNKNOWN FREQUENCY FOR AN UNSPECIFIED INDICATION. THE PATIENT MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PATIENT OPENED THERMACARE BACKPAIN THERAPY L/XL. ONE OF THE WRAPS WAS HAD THE HEAT CELLS OPEN. THE ACTION TAKEN IN RESPONSE FOR THE EVENT AND EVENT OUTCOME WAS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE PROVIDED AS IT BECOMES AVAILABLE. FOLLOW-UP (11FEB2021): THIS CASE IS BEING DELETED FROM THE DATABASE FOR THE FOLLOWING REASON: DUPLICATE CASE. THIS IS A FOLLOW-UP REPORT TO NOTIFY THAT CASES (B)(4) ARE DUPLICATES. ALL SUBSEQUENT INFORMATION WILL BE REPORTED UNDER MANUFACTURER REPORT NUMBER 2021161030. NO FOLLOW-UP ATTEMPTS ARE NEEDED. NO FURTHER INFORMATION IS EXPECTED.

    Description of Event or Problem · 0

    EVENT VERBATIM [PREFERRED TERM] HAD THE HEAT CELLS OPEN [DEVICE LEAKAGE], , NARRATIVE: THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER (PATIENT). THIS CONSUMER REPORTED TWO DEVICES. THIS IS THE SECOND OF 2 REPORTS. A PATIENT OF UNSPECIFIED AGE AND GENDER STARTED TO RECEIVE THERMACARE HEATWRAP (THERMACARE LOWER BACK & HIP), DEVICE LOT NUMBER BK2631, EXPIRATION DATE JAN2023, VIA AN UNSPECIFIED ROUTE OF ADMINISTRATION FROM AN UNSPECIFIED DATE AT AN UNKNOWN FREQUENCY FOR AN UNSPECIFIED INDICATION. THE PATIENT MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PATIENT OPENED THERMACARE BACKPAIN THERAPY L/XL. ONE OF THE WRAPS WAS HAD THE HEAT CELLS OPEN. THE ACTION TAKEN IN RESPONSE FOR THE EVENT AND EVENT OUTCOME 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
    299595 THERMACARE LOWER BACK & HIP DISPOSABLE PACK, HOT IMD PFIZER CONSUMER HEALTH CARE BK2631

    Patients

    Seq Age Sex Outcome Treatment
    1