BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACARE LOWER BACK & HIP

    MDR report key: 6034229 · Received October 17, 2016

    Report

    Report Number
    1066015-2016-00132
    Event Type
    Injury
    Date Received
    October 17, 2016
    Date of Event
    October 1, 2016
    Report Date
    October 11, 2016
    Manufacturer
    PFIZER CONSUMER HEALTH CARE
    Product Code
    IMD
    PMA / PMN Number
    K953442
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS INVESTIGATION WAS CONDUCTED FOR AN UNKNOWN LOT NUMBER LOWER BACK/HIP (LBH) 8-HOUR PRODUCT. THE ROOT CAUSE CATEGORY IS NON-ASSIGNABLE (COMPLAINT NOT CONFIRMED AS A QUALITY DEFECT). THERE WAS LIMITED DEVICE SPECIFIC INFORMATION PROVIDED, NO BATCH NUMBER OR RETURN SAMPLE WAS AVAILABLE FOR EVALUATION. WITHOUT A BATCH REFERENCE NUMBER, A MANUFACTURING AND TECHNICAL EVALUATION CANNOT BE COMPLETED FOR THE WRAP INVOLVED IN THIS CASE. THERE IS NOT A PRODUCT QUALITY RELATED TREND IDENTIFIED FOR THE SUBCLASS ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION. THE MANUFACTURING OPERATIONS EMPLOY QUALITY CONTROL PROCEDURES WHICH INCLUDE IN PROCESS TESTING, THERMAL TESTING AND VISUAL INSPECTION, TO ENSURE THE QUALITY OF THE PRODUCT BEING PACKAGED.

    Description of Event or Problem · 0

    EVENT VERBATIM [PREFERRED TERM] TWO BLISTERS ON HER BACK [BLISTER] , . CASE NARRATIVE:THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER RECEIVED VIA A SALES REPRESENTATIVE. A FEMALE PATIENT OF AN UNSPECIFIED AGE STARTED TO RECEIVE THERMACARE HEATWRAP (THERMACARE LOWER BACK & HIP) FROM (B)(6) 2016 15:00 TO (B)(6) 2016 22:30 AT UNKNOWN DOSE FOR BACK PAIN. THE PATIENT MEDICAL HISTORY WAS NOT REPORTED. THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. SALES REPRESENTATIVE DID A THERMACARE TRAINING WITH PHARMACY STAFF LAST WEEK 3OCT. THE THERMACARE SAMPLE THAT WAS USED TO SHOW HOW IT HEATS UP AND HOW ITS PUT ON, SALES REPRESENTATIVE PUT ON ONE OF THE STAFF MEMBERS TO WEAR FOR THE DAY FOR THE RELIEVE OF HER BACK PAIN. SALES REPRESENTATIVE PUT IT ON FOR HER OVER A VEST THAT SHE WAS WEARING. TODAY ((B)(6) 2016) WHEN SALES REPRESENTATIVE ENTERED STORE, SALES REPRESENTATIVE WAS GIVEN THE INFORMATION THAT SHE HAD EXPERIENCED TWO BLISTERS ON HER BACK IN (B)(6) 2016 FROM WEARING IT. THERMACARE LBH WAS ON HER BACK FROM 15:00 TO 22:30. THE ACTION TAKEN IN RESPONSE TO THE EVENT FOR THERMACARE HEATWRAP WAS UNKNOWN. EVENT OUTCOME WAS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE PROVIDED AS IT BECOMES AVAILABLE. AMENDMENT: THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO AMEND PREVIOUSLY REPORTED INFORMATION: ONSET DATE OF THE EVENT ADDED AND TRADE NAME OF THE DEVICE UPDATED. COMPANY CLINICAL EVALUATION COMMENT BASED ON THE INFORMATION PROVIDED, THE REPORTED EVENT BLISTER AS DESCRIBED IN THIS CASE IS CONSIDERED SERIOUS BODILY INJURIES POTENTIALLY REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT DAMAGE OR IMPAIRMENT OF BODY STRUCTURE, ASSESSED AS ASSOCIATED WITH THE USE OF THE DEVICE., COMMENT: BASED ON THE INFORMATION PROVIDED, THE REPORTED EVENT BLISTER AS DESCRIBED IN THIS CASE IS CONSIDERED SERIOUS BODILY INJURIES POTENTIALLY REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT DAMAGE OR IMPAIRMENT OF BODY STRUCTURE, ASSESSED AS ASSOCIATED WITH THE USE OF THE DEVICE.

    Description of Event or Problem · 0

    EVENT VERBATIM [PREFERRED TERM]. TWO BLISTERS ON HER BACK [BLISTER]. NARRATIVE: THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER RECEIVED VIA A SALES REPRESENTATIVE. A FEMALE PATIENT OF AN UNSPECIFIED AGE STARTED TO RECEIVE THERMACARE HEATWRAP (THERMACARE LOWER BACK & HIP) FROM (B)(6) 2016 15:00 TO (B)(6) 2016 22:30 AT UNKNOWN DOSE FOR BACK PAIN. THE PATIENT'S MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. SALES REPRESENTATIVE DID A THERMACARE TRAINING WITH PHARMACY STAFF LAST WEEK (B)(6). THE THERMACARE SAMPLE THAT WAS USED TO SHOW HOW IT HEATS UP AND HOW ITS PUT ON, SALES REPRESENTATIVE PUT ON ONE OF THE STAFF MEMBERS TO WEAR FOR THE DAY FOR THE RELIEVE OF HER BACK PAIN. SALES REPRESENTATIVE PUT IT ON FOR HER OVER A VEST THAT SHE WAS WEARING. TODAY (B)(6) 2016 WHEN SALES REPRESENTATIVE ENTERED STORE, SALES REPRESENTATIVE WAS GIVEN THE INFORMATION THAT SHE HAD EXPERIENCED TWO BLISTERS ON HER BACK IN (B)(6) 2016 FROM WEARING IT. THERMACARE LBH WAS ON HER BACK FROM 15:00 TO 22:30. THE ACTION TAKEN IN RESPONSE TO THE EVENT FOR THERMACARE HEATWRAP WAS UNKNOWN. EVENT OUTCOME WAS UNKNOWN. ACCORDING TO PRODUCT QUALITY COMPLAINTS: THIS INVESTIGATION WAS CONDUCTED FOR AN UNKNOWN LOT NUMBER LOWER BACK/HIP (LBH) 8-HOUR PRODUCT. THE ROOT CAUSE CATEGORY IS NON-ASSIGNABLE (COMPLAINT NOT CONFIRMED AS A QUALITY DEFECT). THERE WAS LIMITED DEVICE SPECIFIC INFORMATION PROVIDED, NO BATCH NUMBER OR RETURN SAMPLE WAS AVAILABLE FOR EVALUATION. WITHOUT A BATCH REFERENCE NUMBER, A MANUFACTURING AND TECHNICAL EVALUATION CANNOT BE COMPLETED FOR THE WRAP INVOLVED IN THIS CASE. THERE IS NOT A PRODUCT QUALITY RELATED TREND IDENTIFIED FOR THE SUBCLASS ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION. THE MANUFACTURING OPERATIONS EMPLOY QUALITY CONTROL PROCEDURES WHICH INCLUDE IN PROCESS TESTING, THERMAL TESTING AND VISUAL INSPECTION, TO ENSURE THE QUALITY OF THE PRODUCT BEING PACKAGED. AMENDMENT: THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO AMEND PREVIOUSLY REPORTED INFORMATION: ONSET DATE OF THE EVENT ADDED AND TRADE NAME OF THE DEVICE UPDATED. FOLLOW-UP (29JUL2020): NEW INFORMATION REPORTED FROM THE PRODUCT QUALITY COMPLAINTS GROUP INCLUDES INVESTIGATION RESULTS., COMMENT: BASED ON THE INFORMATION PROVIDED, THE REPORTED EVENT BLISTER AS DESCRIBED IN THIS CASE IS CONSIDERED SERIOUS BODILY INJURIES POTENTIALLY REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT DAMAGE OR IMPAIRMENT OF BODY STRUCTURE, ASSESSED AS ASSOCIATED WITH THE USE OF THE DEVICE.

    Description of Event or Problem · 1

    EVENT VERBATIM [PREFERRED TERM] TWO BLISTERS ON HER BACK [BLISTER] , . CASE NARRATIVE:THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER RECEIVED VIA A SALES REPRESENTATIVE. A FEMALE PATIENT OF AN UNSPECIFIED AGE AND ETHNICITY STARTED TO RECEIVE THERMACARE HEATWRAP (THERMACARE HEATWRAP) FROM (B)(6) 2016 15:00 TO (B)(6) 2016 22:30 AT UNKNOWN DOSE FOR BACK PAIN. THE PATIENT MEDICAL HISTORY WAS NOT REPORTED. THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. SALES REPRESENTATIVE DID A THERMACARE TRAINING WITH PHARMACY STAFF LAST WEEK 3OCT. THE THERMACARE SAMPLE THAT WAS USED TO SHOW HOW IT HEATS UP AND HOW ITS PUT ON, SALES REPRESENTATIVE PUT ON ONE OF THE STAFF MEMBERS TO WEAR FOR THE DAY FOR THE RELIEVE OF HER BACK PAIN. SALES REPRESENTATIVE PUT IT ON FOR HER OVER A VEST THAT SHE WAS WEARING. TODAY (11OCT2016) WHEN SALES REPRESENTATIVE ENTERED STORE, SALES REPRESENTATIVE WAS GIVEN THE INFORMATION THAT SHE HAD EXPERIENCED TWO BLISTERS ON HER BACK FROM WEARING IT. THERMACARE LBH WAS ON HER BACK FROM 15:00 TO 22:30. EVENT OUTCOME WAS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE PROVIDED AS IT BECOMES AVAILABLE. COMPANY CLINICAL EVALUATION COMMENT BASED ON THE INFORMATION PROVIDED, THE REPORTED EVENT BLISTER AS DESCRIBED IN THIS CASE IS CONSIDERED SERIOUS BODILY INJURIES POTENTIALLY REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT DAMAGE OR IMPAIRMENT OF BODY STRUCTURE, ASSESSED AS ASSOCIATED WITH THE USE OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684997 THERMACARE LOWER BACK & HIP DISPOSABLE PACK, HOT IMD PFIZER CONSUMER HEALTH CARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention