BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACARE LOWER BACK & HIP

    MDR report key: 4763390 · Received May 8, 2015

    Report

    Report Number
    1066015-2015-00041
    Event Type
    Injury
    Date Received
    May 8, 2015
    Report Date
    April 30, 2015
    Manufacturer
    PFIZER CONSUMER HEALTH CARE
    Product Code
    IMD
    PMA / PMN Number
    K953442
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE PROVIDED AS IT BECOMES AVAILABLE. COMPANY CLINICAL EVALUATION COMMENT: BASED ON THE INFORMATION PROVIDED, THE EVENT BURN BLISTER AS DESCRIBED IN THIS CASE IS CONSIDERED A 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. THIS CASE MEETS INITIAL 10-DAY EU AND 30-DAY FDA REPORTABILITY.

    Description of Event or Problem · 1

    BURN BLISTER [BURNS SECOND DEGREE]. CASE DESCRIPTION: THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE PHARMACIST VIA PCH (PFIZER CONSUMER HEALTH CARE). A (B)(6) FEMALE PATIENT STARTED TO USE THERMACARE HEATWRAP (THERMACARE LOWER BACK AND HIP), FROM AN UNSPECIFIED DATE TO AN UNSPECIFIED DATE AT AN UNSPECIFIED FREQUENCY FOR AN UNSPECIFIED INDICATION. THE PATIENT MEDICAL HISTORY WAS NOT REPORTED. THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PATIENT EXPERIENCED A BURN BLISTER ON AN UNSPECIFIED DATE. THE ACTION TAKEN IN RESPONSE TO THE EVENT FOR THERMACARE HEATWRAP WAS PERMANENTLY WITHDRAWN ON AN UNSPECIFIED DATE. THE OUTCOME OF THE EVENT WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303403 THERMACARE LOWER BACK & HIP DISPOSABLE PACK, HOT IMD PFIZER CONSUMER HEALTH CARE

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention