BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACARE HEATWRAP

    MDR report key: 4600745 · Received March 11, 2015

    Report

    Report Number
    1066015-2015-00008
    Event Type
    Injury
    Date Received
    March 11, 2015
    Date of Event
    February 20, 2015
    Report Date
    March 2, 2015
    Manufacturer
    PFIZER CONSUMER HEALTH CARE
    Product Code
    IMD
    PMA / PMN Number
    K953442
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    SEVERAL UP TO 3 CM LARGE BLISTERS IN THE LUMBAR SPINE AREA / PAINFUL BURN: GRADE 2 [BURNS SECOND DEGREE] SHE WENT WITHOUT HESITATION WITH THE APPLIED HEATWRAP TO BED [DEVICE MISUSE]. CASE DESCRIPTION: THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER OR OTHER NON HCP. A (B)(6) FEMALE PATIENT OF AN UNSPECIFIED ETHNICITY STARTED TO RECEIVE THERMACARE HEATWRAP (THERMACARE HEATWRAP) FROM (B)(6) 2015 FOR BACK PAIN. THE PATIENT'S MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PATIENT REPORTED THAT SHE WAS FAMILIAR WITH THE APPLICATION OF HEATWRAPS, SO SHE WENT WITHOUT HESITATION WITH THE APPLIED HEATWRAP ON (B)(6) 2015 TO BED. AFTER LESS THAN 6 HOURS AT 3 O'CLOCK IN THE MORNING, SHE WOKE UP BECAUSE OF BURNING PAIN AND IMMEDIATELY REMOVED THE HEATWRAP. SHE EXPERIENCED SEVERAL PAINFUL BLISTERS. SHE VISITED A PHYSICIAN ON (B)(6) 2015 DUE TO THE BLISTERS. THE FOLLOWING ATTEST WAS PROVIDED: PATIENT EXPERIENCED A PAINFUL BURN: GRADE 2 (SEVERAL UP TO 3 CM LARGE BLISTERS IN THE LUMBAR SPINE AREA). THE PATIENT RECEIVED WOUND TREATMENT (FOAM DRESSING AND THE ADMINISTRATION OF PAINKILLER. ACTION TAKEN WITH THE PRODUCT WAS PERMANENTLY WITHDRAWN ON (B)(6) 2015. AT THE TIME OF THE REPORT, CLINICAL OUTCOME OF THE EVENTS WAS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE PROVIDED AS IT BECOMES AVAILABLE. COMPANY COMMENT: BASED ON THE AVAILABLE INFORMATION, THE COMPANY CANNOT EXCLUDE A POSSIBLE CONTRIBUTION OF THE SUSPECT DEVICE PRODUCT (THERMACARE HEATWRAP) TO THE EVENTS OF SEVERAL UP TO 3 CM LARGE BLISTERS IN THE LUMBAR SPINE AREA / PAINFUL BURN: GRADE 2. THIS CASE IS MEDICALLY ASSESSED AS SERIOUS AND INITIAL REPORTABLE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168326 THERMACARE HEATWRAP DISPOSABLE PACK, HOT IMD PFIZER CONSUMER HEALTH CARE

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention