BEUDAMED
    FDA Adverse Event Other Summary report: N

    THERMACARE LOWER BACK AND HIP

    MDR report key: 4649709 · Received March 26, 2015

    Report

    Report Number
    1066015-2015-00010
    Event Type
    Other
    Date Received
    March 26, 2015
    Date of Event
    March 4, 2015
    Report Date
    March 6, 2015
    Manufacturer
    PFIZER CONSUMER HEALTH CARE
    Product Code
    IMD
    PMA / PMN Number
    K953442
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    CASE COMMENT: BASED ON THE INFORMATION PROVIDED, A POSSIBLE CONTRIBUTORY ROLE OF THE SUSPECT DRUG TO THE REPORTED EVENTS BURNS, SECOND DEGREE CANNOT BE EXCLUDED. THIS CASE MEETS 30 DAY REPORTABILITY.

    Description of Event or Problem · 1

    FOLLOW-UP (03/24/2015): INFORMATION RECEIVED FROM A CONTACTABLE CONSUMER INCLUDES: THE PATIENT DENIED ANY CONCOMITANT MEDICATION AND DENIED HOSPITALIZATION AS A RESULT OF THE EVENTS. DURING REVIEW OF THIS FOLLOW-UP, IT WAS DETERMINED THE PREVIOUSLY REPORTED EVENT "DID NOT CHECK THE SKIN UNDER THE WRAP DURING USE", CODED TO DEVICE MISUSE, SHOULD BE REMOVED AS AN EVENT AS THE CONSUMER INDICATED THEY HAD ONLY WORN THE HEATWRAP FOR APPROXIMATELY 30 MINUTES BEFORE THEY EXPERIENCED 1ST AND 2ND DEGREE BURNS.

    Description of Event or Problem · 1

    BLISTER, SECOND DEGREE BURNS ON LOWER BACK/CAUSED 2ND DEGREE BURNS [BURNS SECOND DEGREE] DID NOT CHECK THE SKIN UNDER THE WRAP DURING USE [DEVICE MISUSE] IT BURNED HIM/FIRST AND SECOND DEGREE BURNS ON LOWER BACK/CAUSED 2ND DEGREE BURNS [BURNS FIRST DEGREE]. CASE DESCRIPTION: THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER. A (B)(6) MALE PT OF AN UNSPECIFIED ETHNICITY STARTED TO RECEIVE THERMACARE HEATWRAP (THERMACARE LOWER BACK AND HIP) (LOT#: L16818, EXP DATE: 11/2017) VIA AN UNSPECIFIED ROUTE OF ADMINISTRATION FROM (B)(6) 2015 FOR LOWER BACK PAIN. THE PT'S MEDICAL HISTORY INCLUDED PSORIASIS. HE IS CURRENTLY UNDER THE CARE OF A PHYSICIAN FOR AN UNSPECIFIED INDICATION. CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON (B)(6) 2015, THE PT REPORTED USING THE HEATWRAP FOR THE 1ST TIME FOR APPROXIMATELY 30 MINUTES AND EXPERIENCED 1ST AND 2ND DEGREE BURNS WITH BLISTERS ON HIS LOWER BACK. HE MENTIONED HE DID NOT CHECK THE SKIN UNDER THE HEATWRAP WHILE IN USE. THE PT STATED HE STARTED TO FEEL THE BURN AND REMOVED THE HEATWRAP. HE REPORTED THE HEATWRAP MATCHES THE BURN MARKS ON HIS BACK. THE PT REPORTED HE WENT TO THE DOCTOR ON (B)(6) 2015 AND THE PHYSICIAN SAID MOST OF THE BURNS WERE 1ST DEGREE BURNS BUT THERE WAS A POPPED BLISTER, CLASSIFIED AS A 2ND DEGREE BURN. THE PHYSICIAN PRESCRIBED SILVADENE AND A RECOMMENDED A MOISTURIZER FOR THE BURN. THE PT BECAME IRATE AND TREATED TO RETAIN A LAWYER AND CONTACT THE MEDIA. THE PT ASSESS HIS SKIN TONE VERY LIGHT OR FAIR. THE PT REPORTED PREVIOUSLY USING HEATING PADS ON (B)(6) 2015 UNSPECIFIED INDICATION. CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON (B)(6) 2015, THE PT REPORTED USING THE HEATWRAP FOR THE 1ST TIME FOR APPROXIMATELY 30 MINUTES AND EXPERIENCED 1ST AND 2ND DEGREE BURNS WITH BLISTERS ON HIS LOWER BACK. HE MENTIONED HE DID NOT CHECK THE SKIN UNDER THE HEATWRAP WHILE IN USE. THE PT STATED HE STARTED TO FEEL THE BURN AND REMOVED THE HEATWRAP. HE REPORTED THE HEATWRAP MATCHES THE BURN MARKS ON HIS BACK. THE PT REPORTED HE WENT TO THE DOCTOR ON (B)(6) 2015 AND THE PHYSICIAN SAID MOST OF THE BURNS WERE 1ST DEGREE BURNS BUT THERE WAS A POPPED BLISTER, CLASSIFIED AS A 2ND DEGREE BURN. THE PHYSICIAN PRESCRIBED SILVADENE AND A RECOMMENDED A MOISTURIZER FOR THE BURN. THE PT BECAME IRATE AND THREATENED TO RETAIN A LAWYER AND CONTACT THE MEDIA. THE PT ASSESS HIS SKIN TONE VERY LIGHT OR FAIR. THE PT REPORTED PREVIOUSLY USING HEATING PADS ON (B)(6) 2015 FOR ABOUT AN HOUR AND ICY HOT PATCHES ON AN UNSPECIFIED DATE BOTH WITH NO REPORTED PROBLEMS. HE DENIED HAVING SENSITIVE SKIN. THE PT DID NOT EXERCISE WHILE USING THE HEATWRAP AND WAS NOT TAKING ANY OTHER MEDICATIONS, INCLUDING OVER THE COUNTER, HERBAL, NUTRITIONAL OR ANY APPLIED TO THE SKIN, DURING THE TIME OF THE BURNS. HE MENTIONED HE DID READ THE INSTRUCTIONS PRIOR TO USING THE HEATWRAP. ACTION TAKEN WITH THE PRODUCT WAS PERMANENTLY WITHDRAWN ON (B)(6) 2015. THERAPEUTIC MEASURES TAKEN INCLUDED SILVADENE PRESCRIPTION AND MOISTURIZER AS TREATMENT FOR BURN. CLINICAL OUTCOME OF THE EVENTS WAS REPORTED AS RESOLVING. ADDITIONAL INFO HAS BEEN REQUESTED AND WILL BE PROVIDED AS IT BECOMES AVAILABLE. FOLLOW-UP (03/06/2015): NEW INFO RECEIVED FROM A CONTACTABLE CONSUMER INCLUDES: PT AGE, MEDICAL HISTORY, UPDATED SUSPECT PRODUCT, LOT NUMBER AND EXPIRATION DATE, PRODUCT START AND STOP DATES, SUSPECT PRODUCT INDICATION, ACTION TAKEN WITH SUSPECT PRODUCT, NEW EVENTS OF DEVICE MISUSE, 1ST DEGREE BURNS AND 2ND DEGREE BURNS, EVENT ONSET DATE, THERAPEUTIC MEASURES TAKEN AND EVENT OUTCOME. THIS CASE WAS UPGRADED TO SERIOUS FOR INTERVENTION REQUIRED. COMPANY CASE COMMENT: BASED ON THE INFO PROVIDED, A POSSIBLE CONTRIBUTOR ROLE OF THE SUSPECT DRUG TO THE REPORTED EVENTS BURNS SECOND DEGREE AND DEVICE MISUSE CANNOT BE EXCLUDED. THIS CASE MEETS INITIAL 30 DAY REPORTABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201978 THERMACARE LOWER BACK AND HIP DISPOSABLE PACK, HOT IMD PFIZER CONSUMER HEALTH CARE L16818

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Male Required Intervention