BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACARE LOWER BACK & HIP

    MDR report key: 9257254 · Received October 30, 2019

    Report

    Report Number
    1066015-2019-00278
    Event Type
    Injury
    Date Received
    October 30, 2019
    Date of Event
    October 24, 2016
    Report Date
    October 25, 2016
    Manufacturer
    PFIZER CONSUMER HEALTH CARE
    Product Code
    IMD
    PMA / PMN Number
    K953442
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SITE SAMPLE STATUS WAS NOT RECEIVED. BATCH G87218 IS THE ONLY BATCH WITHIN THE SCOPE OF THIS INVESTIGATION. THERMACARE BATCHES ARE PRODUCED AS INDIVIDUAL LOTS. THE DEVICE HISTORY RECORD (DHR) AND TRENDING WERE EVALUATED. NO QUALITY ISSUES WERE IDENTIFIED. CONCLUSION WAS AS FOLLOWS: THE ROOT CAUSE CATEGORY IS NON ASSIGNABLE (COMPLAINT NOT CONFIRMED AS A QUALITY DEFECT). AFTER A REVIEW OF THE BATCH THERMAL RECORDS, THERMAL RESULTS ALL MET PRODUCT RELEASE CRITERIA. CONSUMER REPORTS THE WRAP CAUSED "BURNED". THE CAUSE OF THE CONSUMER STATING THE WRAP CAUSED A BURNED IS INCONCLUSIVE SINCE REVIEW OF RECORDS DOES NOT PROVIDE EVIDENCE TO SUPPORT DEFECTIVE PRODUCT. THE PLANT HAS REVIEWED THIS BATCH FROM A MANUFACTURING PERSPECTIVE. NO QUALITY ISSUES WERE IDENTIFIED UPON THIS REVIEW OF BATCH RECORDS, RELEASE TESTING DATA. RETAINED SAMPLES INSPECTION NOT AVAILABLE AS THE PRODUCT AT THE TIME OF THE INVESTIGATION WAS WRITTEN HAS EXPIRED. EXPIRY DATE WAS MAR2016. THE PRODUCT QUALITY FOR THE BATCH IS NOT IMPACTED BY THIS COMPLAINT. LOT TREND ASSMT. & RATIONALE WAS: AN EVALUATION OF THE COMPLAINT HISTORY CONFIRMS THAT THIS IS THE FIRST COMPLAINT FOR THE SUB CLASS ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION RECEIVED AT THE ALBANY SITE REQUIRING AN EVALUATION FOR THIS BATCH. PER SOP #, COMPLAINT TRENDING GUIDELINE, EFFECTIVE 24FEB2020, THE COMPLAINT WAS EVALUATED TO IDENTIFY A POTENTIAL TREND BY CALCULATING THE COMPLAINTS PER MILLION PRODUCED (CPMP) OF THE SUBCLASS AND LOT. THE CALCULATED CPMP RESULT OF 7 WAS BELOW THE UPPER CONTROL LIMIT (UCL) OF 33.9. A TREND WAS NOT IDENTIFIED. ON THE BASIS OF THIS EVALUATION, A TREND DOES NOT EXIST FOR THIS BATCH.

    Description of Event or Problem · 0

    EVENT VERBATIM [PREFERRED TERM] BURNED HER LOWER BACK [THERMAL BURN] , FELT THE WRAP WAS GETTING TOO HOT [DEVICE ISSUE] , EXPIRATION DATE IS 31MAR2016 [EXPIRED DEVICE USED]. CASE NARRATIVE:THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER. A 55-YEAR-OLD FEMALE PATIENT STARTED TO RECEIVE THERMACARE HEATWRAP (THERMACARE LOWER BACK & HIP) DEVICE LOT NUMBER G87218, EXPIRATION DATE 31MAR2016, FROM (B)(6) 2016 TO AN UNSPECIFIED DATE AT AN UNKNOWN FREQUENCY FOR LOWER BACK AND HIP PAIN. MEDICAL HISTORY WAS NONE. THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PATIENT HAD PUT ON A THERMACARE HEAT WRAP FOR THE LOWER BACK AND HIP FOR THE FIRST TIME YESTERDAY ((B)(6) 2016); AND REPORTED IT BURNED HER LOWER BACK ON (B)(6) 2016. SHE HAD USED THERMACARE HEATWRAP JUST FOR 3 HOURS AND THEN SHE TOOK IT OFF BECAUSE IT WAS BURNING HER. THE PATIENT HAD BURNS ON HER RIGHT LOWER BACK. THERE WAS NO DRAINAGE OR PUS FROM THE BURNS. THERAPEUTIC MEASURES TAKEN AS A RESULT OF BURNED HER LOWER BACK INCLUDED BACITRACIN AND BAND AIDS. SHE CLASSIFIED HER SKIN TONE AS MEDIUM. SHE DID NOT USE ANY CREAMS, RUBS OR GELS UNDER THE WRAP. SHE DID NOT USE THERMACARE HEATWRAP IN THE PAST. THERE WERE NO DEFECTS IN THE WRAP. SHE DID NOT CHANGE OR MODIFY THE WRAP AND DID NOT PUT IT IN THE MICROWAVE. SHE DID NOT USE THE WRAP OVERNIGHT OR WHILE SLEEPING. SHE USED THE WRAP OVER HEALTHY SKIN AND ON THE CORRECT PART OF THE BODY. SHE DID NOT EXERCISE WHILE USING THE WRAP. SHE DID NOT APPLY PRESSURE OVER THE WRAP. SHE DID NOT WEAR MORE THAN TWO LAYERS OF CLOTHING OVER THE WRAP. SHE DID NOT SIT OR RECLINE FOR A PROLONGED PERIOD OF TIME. SHE DID NOT USE MORE THAN ONE WRAP PER DAY. SHE USED THE WRAP FOR THREE HOURS. SHE FELT THE WRAP WAS GETTING TOO HOT. LABORATORY WORK WAS NONE. THE ACTION TAKEN WITH THERMACARE HEATWRAP WAS PERMANENTLY WITHDRAWN. THE OUTCOME OF EVENT WAS NOT RESOLVED. FOLLOW-UP (02DEC2016): FOLLOW-UP ATTEMPTS ARE COMPLETED. NO FURTHER INFORMATION IS EXPECTED. FOLLOW-UP (25OCT2016): THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO UPGRADE THIS CASE TO A REPORTABLE MDR. FOLLOW-UP (21NOV2019): NEW INFORMATION RECEIVED IN RESPONSE TO A QUERY CLARIFYING THE EXPIRATION DATE OF THERMACARE HEATWRAP WHICH STATED ACCORDING TO THE SAP LOOKUP FOR G87218, THE EXPIRATION DATE IS 31MAR2016. COMPANY CLINICAL EVALUATION COMMENT: BASED ON THE INFORMATION PROVIDED, THE EVENTS THERMAL BURN AND DEVICE ISSUE AS DESCRIBED ARE CONSIDERED SERIOUS BODILY INJURY REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT DAMAGE OR IMPAIRMENT OF BODY STRUCTURE. THE EVENT EXPIRED DEVICE USED IS NON-SERIOUS. THE EVENTS ARE MEDICALLY ASSESSED AS ASSOCIATED WITH THE USE OF THE DEVICE., COMMENT: BASED ON THE INFORMATION PROVIDED, THE EVENTS THERMAL BURN AND DEVICE ISSUE AS DESCRIBED ARE CONSIDERED SERIOUS BODILY INJURY REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT DAMAGE OR IMPAIRMENT OF BODY STRUCTURE. THE EVENT EXPIRED DEVICE USED IS NON-SERIOUS. THE EVENTS ARE MEDICALLY ASSESSED AS ASSOCIATED WITH THE USE OF THE DEVICE.

    Description of Event or Problem · 0

    EVENT VERBATIM [PREFERRED TERM], BURNED HER LOWER BACK [THERMAL BURN], FELT THE WRAP WAS GETTING TOO HOT [DEVICE ISSUE], EXPIRATION DATE IS 31MAR2016 [EXPIRED DEVICE USED], NARRATIVE: THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER. A 55-YEAR-OLD FEMALE PATIENT STARTED TO RECEIVE THERMACARE HEATWRAP (THERMACARE LOWER BACK & HIP) DEVICE LOT NUMBER G87218, EXPIRATION DATE 31MAR2016, FROM (B)(6) 2016 AT AN UNKNOWN FREQUENCY FOR LOWER BACK AND HIP PAIN. MEDICAL HISTORY WAS NONE. THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PATIENT HAD PUT ON A THERMACARE HEAT WRAP FOR THE LOWER BACK AND HIP FOR THE FIRST TIME YESTERDAY ((B)(6) 2016); AND REPORTED IT BURNED HER LOWER BACK ON (B)(6) 2016. SHE HAD USED THERMACARE HEATWRAP JUST FOR 3 HOURS AND THEN SHE TOOK IT OFF BECAUSE IT WAS BURNING HER. THE PATIENT HAD BURNS ON HER RIGHT LOWER BACK. THERE WAS NO DRAINAGE OR PUS FROM THE BURNS. THERAPEUTIC MEASURES TAKEN AS A RESULT OF BURNED HER LOWER BACK INCLUDED BACITRACIN AND BAND AIDS. SHE CLASSIFIED HER SKIN TONE AS MEDIUM. SHE DID NOT USE ANY CREAMS, RUBS OR GELS UNDER THE WRAP. SHE DID NOT USE THERMACARE HEATWRAP IN THE PAST. THERE WERE NO DEFECTS IN THE WRAP. SHE DID NOT CHANGE OR MODIFY THE WRAP AND DID NOT PUT IT IN THE MICROWAVE. SHE DID NOT USE THE WRAP OVERNIGHT OR WHILE SLEEPING. SHE USED THE WRAP OVER HEALTHY SKIN AND ON THE CORRECT PART OF THE BODY. SHE DID NOT EXERCISE WHILE USING THE WRAP. SHE DID NOT APPLY PRESSURE OVER THE WRAP. SHE DID NOT WEAR MORE THAN TWO LAYERS OF CLOTHING OVER THE WRAP. SHE DID NOT SIT OR RECLINE FOR A PROLONGED PERIOD OF TIME. SHE DID NOT USE MORE THAN ONE WRAP PER DAY. SHE USED THE WRAP FOR THREE HOURS. SHE FELT THE WRAP WAS GETTING TOO HOT. LABORATORY WORK WAS NONE. THE ACTION TAKEN WITH THERMACARE HEATWRAP WAS PERMANENTLY WITHDRAWN. THE OUTCOME OF EVENT BURNED HER LOWER BACK AND FELT THE WRAP WAS GETTING TOO HOT WAS NOT RESOLVED. THE OUTCOME OF THE OTHER EVENT WAS UNKNOWN. ACCORDING TO PRODUCT QUALITY GROUP, SITE SAMPLE STATUS WAS NOT RECEIVED. BATCH G87218 IS THE ONLY BATCH WITHIN THE SCOPE OF THIS INVESTIGATION. THERMACARE BATCHES ARE PRODUCED AS INDIVIDUAL LOTS. THE DEVICE HISTORY RECORD (DHR) AND TRENDING WERE EVALUATED. NO QUALITY ISSUES WERE IDENTIFIED. CONCLUSION WAS AS FOLLOWS: THE ROOT CAUSE CATEGORY IS NON ASSIGNABLE (COMPLAINT NOT CONFIRMED AS A QUALITY DEFECT). AFTER A REVIEW OF THE BATCH THERMAL RECORDS, THERMAL RESULTS ALL MET PRODUCT RELEASE CRITERIA. CONSUMER REPORTS THE WRAP CAUSED "BURNED". THE CAUSE OF THE CONSUMER STATING THE WRAP CAUSED A BURNED IS INCONCLUSIVE SINCE REVIEW OF RECORDS DOES NOT PROVIDE EVIDENCE TO SUPPORT DEFECTIVE PRODUCT. THE PLANT HAS REVIEWED THIS BATCH FROM A MANUFACTURING PERSPECTIVE. NO QUALITY ISSUES WERE IDENTIFIED UPON THIS REVIEW OF BATCH RECORDS, RELEASE TESTING DATA. RETAINED SAMPLES INSPECTION NOT AVAILABLE AS THE PRODUCT AT THE TIME OF THE INVESTIGATION WAS WRITTEN HAS EXPIRED. EXPIRY DATE WAS MAR2016. THE PRODUCT QUALITY FOR THE BATCH IS NOT IMPACTED BY THIS COMPLAINT. LOT TREND ASSMT. & RATIONALE WAS: AN EVALUATION OF THE COMPLAINT HISTORY CONFIRMS THAT THIS IS THE FIRST COMPLAINT FOR THE SUB CLASS ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION RECEIVED AT THE ALBANY SITE REQUIRING AN EVALUATION FOR THIS BATCH. PER SOP #, COMPLAINT TRENDING GUIDELINE, EFFECTIVE 24FEB2020, THE COMPLAINT WAS EVALUATED TO IDENTIFY A POTENTIAL TREND BY CALCULATING THE COMPLAINTS PER MILLION PRODUCED (CPMP) OF THE SUBCLASS AND LOT. THE CALCULATED CPMP RESULT OF 7 WAS BELOW THE UPPER CONTROL LIMIT (UCL) OF 33.9. A TREND WAS NOT IDENTIFIED. ON THE BASIS OF THIS EVALUATION, A TREND DOES NOT EXIST FOR THIS BATCH. FOLLOW-UP (02DEC2016): FOLLOW-UP ATTEMPTS ARE COMPLETED. NO FURTHER INFORMATION IS EXPECTED. FOLLOW-UP (25OCT2016): THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO UPGRADE THIS CASE TO A REPORTABLE MDR. FOLLOW-UP (21NOV2019): NEW INFORMATION RECEIVED IN RESPONSE TO A QUERY CLARIFYING THE EXPIRATION DATE OF THERMACARE HEATWRAP WHICH STATED ACCORDING TO THE SAP LOOKUP FOR G87218, THE EXPIRATION DATE IS 31MAR2016. FOLLOW-UP (20DEC2019): FOLLOW-UP ATTEMPTS ARE COMPLETED. NO FURTHER INFORMATION IS EXPECTED. FOLLOW-UP (17JUL2020): NEW INFORMATION RECEIVED FROM PRODUCT QUALITY GROUP INCLUDED: INVESTIGATION RESULTS. FOLLOW-UP ATTEMPTS ARE COMPLETED. NO FURTHER INFORMATION IS EXPECTED.

    Description of Event or Problem · 1

    EVENT VERBATIM [PREFERRED TERM] BURNED HER LOWER BACK [THERMAL BURN], FELT THE WRAP WAS GETTING TOO HOT [DEVICE ISSUE]. THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER. A (B)(6) FEMALE PATIENT STARTED TO RECEIVE (B)(6) HEATWRAP (B)(6) LOWER BACK & HIP) DEVICE LOT NUMBER G87218, EXPIRATION DATE NOV2022, FROM (B)(6) 2016 TO AN UNSPECIFIED DATE AT AN UNKNOWN FREQUENCY FOR LOWER BACK AND HIP PAIN. MEDICAL HISTORY WAS NONE. THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PATIENT HAD PUT ON A (B)(6) HEAT WRAP FOR THE LOWER BACK AND HIP FOR THE FIRST TIME YESTERDAY (B)(6) 2016); AND REPORTED IT BURNED HER LOWER BACK ON (B)(6) 2016. SHE HAD USED (B)(6) HEATWRAP JUST FOR 3 HOURS AND THEN SHE TOOK IT OFF BECAUSE IT WAS BURNING HER. THE PATIENT HAD BURNS ON HER RIGHT LOWER BACK. THERE WAS NO DRAINAGE OR PUS FROM THE BURNS. THERAPEUTIC MEASURES TAKEN AS A RESULT OF BURNED HER LOWER BACK INCLUDED BACITRACIN AND BAND AIDS. SHE CLASSIFIED HER SKIN TONE AS MEDIUM. SHE DID NOT USE ANY CREAMS, RUBS OR GELS UNDER THE WRAP. SHE DID NOT USE (B)(6) HEATWRAP IN THE PAST. THERE WERE NO DEFECTS IN THE WRAP. SHE DID NOT CHANGE OR MODIFY THE WRAP AND DID NOT PUT IT IN THE MICROWAVE. SHE DID NOT USE THE WRAP OVERNIGHT OR WHILE SLEEPING. SHE USED THE WRAP OVER HEALTHY SKIN AND ON THE CORRECT PART OF THE BODY. SHE DID NOT EXERCISE WHILE USING THE WRAP. SHE DID NOT APPLY PRESSURE OVER THE WRAP. SHE DID NOT WEAR MORE THAN TWO LAYERS OF CLOTHING OVER THE WRAP. SHE DID NOT SIT OR RECLINE FOR A PROLONGED PERIOD OF TIME. SHE DID NOT USE MORE THAN ONE WRAP PER DAY. SHE USED THE WRAP FOR THREE HOURS. SHE FELT THE WRAP WAS GETTING TOO HOT. LABORATORY WORK WAS NONE. THE ACTION TAKEN WITH (B)(6) HEATWRAP WAS PERMANENTLY WITHDRAWN. THE OUTCOME OF EVENT WAS NOT RESOLVED. FOLLOW-UP (02DEC2016): FOLLOW-UP ATTEMPTS ARE COMPLETED. NO FURTHER INFORMATION IS EXPECTED. FOLLOW-UP (25OCT2016): THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO UPGRADE THIS CASE TO A REPORTABLE MDR. COMPANY CLINICAL EVALUATION COMMENT: BASED ON THE INFORMATION PROVIDED, THE EVENTS THERMAL BURN AND THERMAL BURN AS DESCRIBED ARE CONSIDERED SERIOUS BODILY INJURY POTENTIALLY REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT DAMAGE OR IMPAIRMENT OF BODY STRUCTURE. THE EVENTS ARE MEDICALLY ASSESSED AS ASSOCIATED WITH THE USE OF THE DEVICE. BASED ON THE INFORMATION PROVIDED, THE EVENTS THERMAL BURN AND THERMAL BURN AS DESCRIBED ARE CONSIDERED SERIOUS BODILY INJURY POTENTIALLY REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT DAMAGE OR IMPAIRMENT OF BODY STRUCTURE. THE EVENTS ARE MEDICALLY ASSESSED AS ASSOCIATED WITH THE USE OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1048302 THERMACARE LOWER BACK & HIP DISPOSABLE PACK, HOT IMD PFIZER CONSUMER HEALTH CARE G87218

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention