BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROBAX LOWER BACK & HIP HEATWRAP

    MDR report key: 10501831 · Received September 8, 2020

    Report

    Report Number
    1066015-2020-00160
    Event Type
    Injury
    Date Received
    September 8, 2020
    Date of Event
    August 23, 2020
    Report Date
    September 1, 2020
    Manufacturer
    PFIZER CONSUMER HEALTHCARE (CANADA)
    Product Code
    IMD
    PMA / PMN Number
    K953442
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SUMMARY OF INVESTIGATION: BATCH AW2092 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: 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, ''1ST DEGREE BURN''. THE CAUSE OF THE CONSUMER STATING THE WRAP CAUSED 1ST DEGREE BURN IS INCONCLUSIVE SINCE REVIEW OF RECORDS DOES NOT PROVIDE EVIDENCE TO SUPPORT DEFECTIVE PRODUCT. THE PRODUCT EFFECT MAY VARY WITH EACH INDIVIDUAL. THE PLANT HAS REVIEWED THIS BATCH FROM A MANUFACTURING PERSPECTIVE. NO QUALITY ISSUES WERE IDENTIFIED UPON THIS REVIEW OF BATCH RECORDS, RELEASE TESTING DATA OR, INSPECTION OF RETAINED SAMPLES. RETAINED SAMPLES MET THE PRODUCT DESCRIPTION AND THE PRODUCT IS WITHIN EXPIRATION DATE. THE PRODUCT QUALITY FOR THE BATCH IS NOT IMPACTED BY THIS COMPLAINT. ROOT CAUSE/CAPA: PROCESS RELATED WAS NO. FINAL CONFIRMATION STATUS WAS NOT CONFIRMED. LOT TREND ASSESSMENT AND RATIONALE: AN EVALUATION OF THE COMPLAINT HISTORY CONFIRMS THAT THIS IS THE SECOND COMPLAINT FOR THE SUB CLASS ADVERSE EVENT/NEGLIGIBLE MINOR RECEIVED AT THE ALBANY SITE REQUIRING AN EVALUATION FOR THIS BATCH. ON THE BASIS OF THIS EVALUATION, A TREND DOES NOT EXIST FOR THIS LOT. EXPEDITE TREND ASSESSMENT AND RATIONALE: AN EVALUATION WAS MADE BY SEARCHING FOR POSSIBLE TREND FOR THIS SUBCLASS. BASED ON THIS CITI CUSTOMIZABLE SEARCH FOR THE SUBCLASSES OF ADVERSE EVENT/NEGLIGIBLE-MINOR FOR LBH PRODUCTS THE DATA DID NOT SHOW AN INCREASE OVER TIME (24 MONTHS). THERE IS NOT A TREND IDENTIFIED FOR THE SUBCLASS OF ADVERSE EVENT/NEGLIGIBLE-MINOR FOR LBH PRODUCT, REFER TO ATTACHMENT LBH ADVERSE EVENT NEGLIGIBLE-MINOR (B)(6) 2018 TO (B)(6) 2020. SITE SAMPLE STATUS WAS NOT RECEIVED. SUMMARY OF INVESTIGATION: BATCH AW2092 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: THE ROOT CAUSE CATEGORY IS NON ASSIGNABLE (COMPLAINT NOT CONFIRMED). AFTER A REVIEW OF THE BATCH THERMAL RECORDS, THERMAL RESULTS ALL MET PRODUCT RELEASE CRITERIA. CONSUMER REPORTS THE WRAP CAUSED, "BURNING MY SKIN". THE CAUSE OF THE CONSUMER STATING THE WRAP CAUSED "BURNING MY SKIN" IS INCONCLUSIVE SINCE REVIEW OF RECORDS DOES NOT PROVIDE EVIDENCE TO SUPPORT DEFECTIVE PRODUCT. THE PRODUCT EFFECT MAY VARY WITH EACH INDIVIDUAL. THE PLANT HAS REVIEWED THIS BATCH FROM A MANUFACTURING PERSPECTIVE. NO QUALITY ISSUES WERE IDENTIFIED UPON THIS REVIEW OF BATCH RECORDS, RELEASE TESTING DATA OR, INSPECTION OF RETAINED SAMPLES. RETAINED SAMPLES MET THE PRODUCT DESCRIPTION AND THE PRODUCT IS WITHIN EXPIRATION DATE. THE PRODUCT QUALITY FOR THE BATCH IS NOT IMPACTED BY THIS COMPLAINT.FOR THE BATCH. LOT TREND ASSESSMENT AND RATIONALE: AN EVALUATION OF THE COMPLAINT HISTORY CONFIRMS THAT THIS IS THE SECOND COMPLAINT FOR THE SUB CLASS ADVERSE EVENT/SERIOUS/UNKNOWN AT THE ALBANY SITE REQUIRING AN EVALUATION FOR THIS BATCH. THE PREVIOUS INVESTIGATION WAS NOT CONFIRMED TO HAVE A MANUFACTURING ROOT CAUSE RELATED TO THE SUBCLASS. PER SOP 105746, COMPLAINT TRENDING GUIDELINE, EFFECTIVE (B)(6) 2020, A VISUAL EXAMINATION WAS PERFORMED TO IDENTIFY A POTENTIAL TREND FOR THE LOT AND SUBCLASS. A TREND WAS NOT IDENTIFIED. REFER TO CHART ON LOT TRENDING ATTACHMENT AW2092 ADVERSE EVENT SERIOUS UNKNOWN (1) . ON THE BASIS OF THIS EVALUATION, A TREND DOES NOT EXIST FOR THIS LOT. EXPEDITE TREND ASSESSMENT AND RATIONALE: A TREND DOES NOT EXIST FOR THIS BATCH. SITE SAMPLE STATUS WAS NOT RECEIVED. SUMMARY OF INVESTIGATION: BATCH AW2092 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: THE ROOT CAUSE CATEGORY IS NON-ASSIGNABLE (COMPLAINT NOT CONFIRMED AS A QUALITY DEFECT). A RETURN SAMPLE HAS NOT BEEN RECEIVED AT THE SITE FOR EVALUATION, THE COMPLAINT CANNOT BE CONFIRMED. THE PLANT HAS REVIEWED THIS BATCH FROM A MANUFACTURING PERSPECTIVE. NO QUALITY ISSUES WERE IDENTIFIED UPON THIS REVIEW OF BATCH RECORDS, RELEASE TESTING DATA OR, INSPECTION OF RETAINED SAMPLES. RETAINED SAMPLES MET THE PRODUCT DESCRIPTION AND THE PRODUCT IS WITHIN EXPIRATION DATE. THE PRODUCT QUALITY FOR THE BATCH IS NOT IMPACTED BY THIS COMPLAINT. PROCESS RELATED WAS NO. FINAL CONFIRMATION STATUS WAS NOT CONFIRMED. LOT TREND ASSESSMENT AND RATIONALE: AN EVALUATION OF THE COMPLAINT HISTORY CONFIRMS THAT THIS IS THE FIRST COMPLAINT FOR THE SUB CLASS INCORRECT/MISSING/ILLEGIBLE TEXT (EXCEPT LOT/EXP/BATCH INFO) RECEIVED AT THE ALBANY,GA SITE FOR THIS BATCH. ON THE BASIS OF THIS EVALUATION, A TREND DOES NOT EXIST FOR THIS LOT. NO EXPEDITE TREND WAS IDENTIFIED. EXPEDITE TREND ASSESSMENT AND RATIONALE: THIS IS NOT AN EXPEDITE COMPLAINT. SITE SAMPLE STATUS WAS NOT RECEIVED.

    Additional Manufacturer Narrative · 0

    SUMMARY OF INVESTIGATION: BATCH AW2092 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. LOT TREND ASSESSMENT AND RATIONALE: AN EVALUATION OF THE COMPLAINT HISTORY CONFIRMS THAT THIS IS THE SECOND COMPLAINT FOR THE SUB CLASS ADVERSE EVENT/NEGLIGIBLE MINOR RECEIVED AT THE ALBANY SITE REQUIRING AN EVALUATION FOR THIS BATCH. ON THE BASIS OF THIS EVALUATION, A TREND DOES NOT EXIST FOR THIS LOT. EXPEDITE TREND ASSESSMENT AND RATIONALE: AN EVALUATION WAS MADE BY SEARCHING FOR POSSIBLE TREND FOR THIS SUBCLASS. BASED ON THIS CITI CUSTOMIZABLE SEARCH FOR THE SUBCLASSES OF ADVERSE EVENT/NEGLIGIBLE-MINOR FOR LBH PRODUCTS THE DATA DID NOT SHOW AN INCREASE OVER TIME (24 MONTHS). THERE IS NOT A TREND IDENTIFIED FOR THE SUBCLASS OF ADVERSE EVENT/NEGLIGIBLE-MINOR FOR LBH PRODUCT, REFER TO ATTACHMENT LBH ADVERSE EVENT NEGLIGIBLE-MINOR 01-SEP-2018 TO 01-SEP-2020. CONCLUSION: 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, ''1ST DEGREE BURN''. THE CAUSE OF THE CONSUMER STATING THE WRAP CAUSED 1ST DEGREE BURN IS INCONCLUSIVE SINCE REVIEW OF RECORDS DOES NOT PROVIDE EVIDENCE TO SUPPORT DEFECTIVE PRODUCT. THE PRODUCT EFFECT MAY VARY WITH EACH INDIVIDUAL. THE PLANT HAS REVIEWED THIS BATCH FROM A MANUFACTURING PERSPECTIVE. NO QUALITY ISSUES WERE IDENTIFIED UPON THIS REVIEW OF BATCH RECORDS, RELEASE TESTING DATA OR, INSPECTION OF RETAINED SAMPLES. RETAINED SAMPLES MET THE PRODUCT DESCRIPTION AND THE PRODUCT IS WITHIN EXPIRATION DATE. THE PRODUCT QUALITY FOR THE BATCH IS NOT IMPACTED BY THIS COMPLAINT. ROOT CAUSE/CAPA: PROCESS RELATED WAS NO. FINAL CONFIRMATION STATUS WAS NOT CONFIRMED. SITE SAMPLE STATUS WAS NOT RECEIVED.SITE SAMPLE STATUS: NOT RECEIVED. SUMMARY OF INVESTIGATION: BATCH AW2092 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: THE ROOT CAUSE CATEGORY IS NON ASSIGNABLE (COMPLAINT NOT CONFIRMED). AFTER A REVIEW OF THE BATCH THERMAL RECORDS, THERMAL RESULTS ALL MET PRODUCT RELEASE CRITERIA. CONSUMER REPORTS THE WRAP CAUSED, "BURNING MY SKIN". THE CAUSE OF THE CONSUMER STATING THE WRAP CAUSED "BURNING MY SKIN" IS INCONCLUSIVE SINCE REVIEW OF RECORDS DOES NOT PROVIDE EVIDENCE TO SUPPORT DEFECTIVE PRODUCT. THE PRODUCT EFFECT MAY VARY WITH EACH INDIVIDUAL. THE PLANT HAS REVIEWED THIS BATCH FROM A MANUFACTURING PERSPECTIVE. NO QUALITY ISSUES WERE IDENTIFIED UPON THIS REVIEW OF BATCH RECORDS, RELEASE TESTING DATA OR, INSPECTION OF RETAINED SAMPLES. RETAINED SAMPLES MET THE PRODUCT DESCRIPTION AND THE PRODUCT IS WITHIN EXPIRATION DATE. THE PRODUCT QUALITY FOR THE BATCH IS NOT IMPACTED BY THIS COMPLAINT FOR THE BATCH. LOT TREND ASSMT. & RATIONALE: AN EVALUATION OF THE COMPLAINT HISTORY CONFIRMS THAT THIS IS THE SECOND COMPLAINT FOR THE SUB CLASS ADVERSE EVENT/SERIOUS/UNKNOWN AT THE ALBANY SITE REQUIRING AN EVALUATION FOR THIS BATCH. THE PREVIOUS INVESTIGATION WAS NOT CONFIRMED TO HAVE A MANUFACTURING ROOT CAUSE RELATED TO THE SUBCLASS. PER SOP 105746, COMPLAINT TRENDING GUIDELINE, EFFECTIVE 24FEB2020, A VISUAL EXAMINATION WAS PERFORMED TO IDENTIFY A POTENTIAL TREND FOR THE LOT AND SUBCLASS. A TREND WAS NOT IDENTIFIED. REFER TO CHART ON LOT TRENDING ATTACHMENT AW2092 ADVERSE EVENT SERIOUS UNKNOWN (1) . ON THE BASIS OF THIS EVALUATION, A TREND DOES NOT EXIST FOR THIS LOT. EXPED TREND ASSMT. & RATIONALE: A TREND DOES NOT EXIST FOR THIS BATCH. SITE SAMPLE STATUS: NOT RECEIVED.

    Additional Manufacturer Narrative · 0

    SUMMARY OF INVESTIGATION: BATCH AW2092 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. LOT TREND ASSESSMENT AND RATIONALE: AN EVALUATION OF THE COMPLAINT HISTORY CONFIRMS THAT THIS IS THE SECOND COMPLAINT FOR THE SUB CLASS ADVERSE EVENT/NEGLIGIBLE MINOR RECEIVED AT THE ALBANY SITE REQUIRING AN EVALUATION FOR THIS BATCH. ON THE BASIS OF THIS EVALUATION, A TREND DOES NOT EXIST FOR THIS LOT. EXPEDITE TREND ASSESSMENT AND RATIONALE: AN EVALUATION WAS MADE BY SEARCHING FOR POSSIBLE TREND FOR THIS SUBCLASS. BASED ON THIS CITI CUSTOMIZABLE SEARCH FOR THE SUBCLASSES OF ADVERSE EVENT/NEGLIGIBLE-MINOR FOR LBH PRODUCTS THE DATA DID NOT SHOW AN INCREASE OVER TIME (24 MONTHS). THERE IS NOT A TREND IDENTIFIED FOR THE SUBCLASS OF ADVERSE EVENT/NEGLIGIBLE-MINOR FOR LBH PRODUCT, REFER TO ATTACHMENT LBH ADVERSE EVENT NEGLIGIBLE-MINOR 01-SEP-2018 TO 01-SEP-2020. CONCLUSION: 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, ''1ST DEGREE BURN''. THE CAUSE OF THE CONSUMER STATING THE WRAP CAUSED 1ST DEGREE BURN IS INCONCLUSIVE SINCE REVIEW OF RECORDS DOES NOT PROVIDE EVIDENCE TO SUPPORT DEFECTIVE PRODUCT. THE PRODUCT EFFECT MAY VARY WITH EACH INDIVIDUAL. THE PLANT HAS REVIEWED THIS BATCH FROM A MANUFACTURING PERSPECTIVE. NO QUALITY ISSUES WERE IDENTIFIED UPON THIS REVIEW OF BATCH RECORDS, RELEASE TESTING DATA OR, INSPECTION OF RETAINED SAMPLES. RETAINED SAMPLES MET THE PRODUCT DESCRIPTION AND THE PRODUCT IS WITHIN EXPIRATION DATE. THE PRODUCT QUALITY FOR THE BATCH IS NOT IMPACTED BY THIS COMPLAINT. ROOT CAUSE/CAPA: PROCESS RELATED WAS NO. FINAL CONFIRMATION STATUS WAS NOT CONFIRMED. SITE SAMPLE STATUS WAS NOT RECEIVED.

    Description of Event or Problem · 0

    EVENT VERBATIM [PREFERRED TERM]. HAD 1ST DEGREE BURN IN THE LOCATION HE PLACED THE WRAP/THE AREA THAT GOT BURNED IS EXACTLY WHERE HE PUT IT. IT IS LIKE ALL RED/HE WAS BURNING AND HURTING [APPLICATION SITE BURN], HE WAS NOT SURE IF THIS OCCURRED BECAUSE IT WAS DEFECTIVE OR WHAT [DEVICE ISSUE], , NARRATIVE: THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER (PATIENT). A 51-YEAR-OLD MALE PATIENT STARTED TO USE THERMACARE HEATWRAP (ROBAX LOWER BACK & HIP HEATWRAP), DEVICE LOT NUMBER AW2092, EXPIRATION DATE APR2022, CATALOG # 0 62107 33630 7, DATE OF MANUFACTURE: 23MAY2019 TO 26MAY2019, FROM AN UNSPECIFIED DATE AT AN UNSPECIFIED FREQUENCY FOR BACK PAIN. THE PATIENT MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PATIENT STATED HE USED ROBAX HEATWRAPS ON HIS BACK PAIN AND HE ENDED UP BY BURNING HIS SKIN. HE ASKED IF IT WAS DEFECTIVE OR WHAT. THE PATIENT STATED HE PURCHASED A BOX BECAUSE HE HAD BACK PAIN. HE STATED HE DID NOT SEE A MANUFACTURER NAME LISTED TO PROVIDE. IT CAME WITH 3 HEATWRAPS INSIDE THE BOX. HE USED ONE AND THEN HE TRIED A SECOND ONE AND HAD 1ST DEGREE BURN IN THE LOCATION HE PLACED THE WRAP. THIS OCCURRED TEN DAYS AGO ON (B)(6) 2020. HE STATED HE WENT TO A WALK IN EMERGENCY TYPE CLINIC PLACE. HE INITIALLY WENT THERE FOR THE BACK PAIN AND THAT WAS WHEN HE REALIZED HE HAD AN ACTUAL BURN AND THE DOCTOR TOLD HIM TO CALL AND REPORT THIS. HE WAS TOLD HE HAD A 1ST DEGREE BURN. TREATMENT: TOLD TO PLACE A COLD BAG, LIKE ICE BAG TO COOL IT DOWN. HE WAS ALSO TAKING PILLS FOR THE BACK PAIN HE ALREADY HAD. THIS WAS FOR THE LOWER BACK. HE WAS NOT SURE IF THIS OCCURRED BECAUSE IT WAS DEFECTIVE OR WHAT, CLARIFYING THE AREA THAT GOT BURNED WAS EXACTLY WHERE HE PUT IT. IT WAS LIKE ALL RED. THE BURN HE SAID HE CAN LIVE WITH. HE DID NOT THINK IT WOULD LEAVE A MARK OR ANYTHING. AFTER THE LOT NUMBER SEES 05/25. HE EXPLAINED AFTER APPLYING THIS SECOND HEAT WRAP WHICH CAUSED THE BURN HE DID NOT REALIZE HE FELT A BURNING SENSATION UNTIL 2-3 HOURS AFTER IT WAS ON. HE WAS NOT REALLY PAYING ATTENTION TO IT BECAUSE HE ALREADY HAD BACK PAIN. HE HAD ALREADY HURT HIS BACK PULLING SOMETHING. AT THE TIME HE WAS NOT TAKING ANY OTHER MEDICATION, BUT NOW HE WAS TAKING MEDICATION FOR BACK PAIN. HE HAD GONE TO THE PHARMACY INITIALLY TO TRY AND TREAT THE BACK PAIN HE WAS HAVING HIMSELF. HOWEVER, AFTER APPLYING THE HEATWRAP HE REALIZED HE WAS BURNING AND HURTING SO HE WENT TO THE WALK IN CLINIC AND WAS TREATED. HE TOOK PICTURES OF HOW THE BURN AREA LOOKED. HE NO LONGER HAD THE HEATWRAP THAT CAUSED THE BURN. HE THREW IT AWAY IN THE GARBAGE. HE STILL HAD THE THIRD HEATWRAP THAT WAS IN THE BOX THAT WAS CLOSED. HE WASN'T REALLY CORRELATING ANYTHING TO THE HEATWRAP IN THE BEGINNING. HE WAS WORRYING MORE ABOUT HIS HURT BACK THAN A BURN. THE ACTION TAKEN IN RESPONSE TO THE EVENTS FOR THE PRODUCT WAS UNKNOWN. THE EVENTS OUTCOME WAS RECOVERING. ACCORDING TO THE PRODUCT QUALITY COMPLAINT GROUP ON 1066015-2020-00160 - 32020: SUMMARY OF INVESTIGATION: BATCH AW2092 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: 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, ''1ST DEGREE BURN''. THE CAUSE OF THE CONSUMER STATING THE WRAP CAUSED 1ST DEGREE BURN IS INCONCLUSIVE SINCE REVIEW OF RECORDS DOES NOT PROVIDE EVIDENCE TO SUPPORT DEFECTIVE PRODUCT. THE PRODUCT EFFECT MAY VARY WITH EACH INDIVIDUAL. THE PLANT HAS REVIEWED THIS BATCH FROM A MANUFACTURING PERSPECTIVE. NO QUALITY ISSUES WERE IDENTIFIED UPON THIS REVIEW OF BATCH RECORDS, RELEASE TESTING DATA OR, INSPECTION OF RETAINED SAMPLES. RETAINED SAMPLES MET THE PRODUCT DESCRIPTION AND THE PRODUCT IS WITHIN EXPIRATION DATE. THE PRODUCT QUALITY FOR THE BATCH IS NOT IMPACTED BY THIS COMPLAINT. ROOT CAUSE/CAPA: PROCESS RELATED WAS NO. FINAL CONFIRMATION STATUS WAS NOT CONFIRMED. LOT TREND ASSESSMENT AND RATIONALE: AN EVALUATION OF THE COMPLAINT HISTORY CONFIRMS THAT THIS IS THE SECOND COMPLAINT FOR THE SUB CLASS ADVERSE EVENT/NEGLIGIBLE MINOR RECEIVED AT THE ALBANY SITE REQUIRING AN EVALUATION FOR THIS BATCH. ON THE BASIS OF THIS EVALUATION, A TREND DOES NOT EXIST FOR THIS LOT. EXPEDITE TREND ASSESSMENT AND RATIONALE: AN EVALUATION WAS MADE BY SEARCHING FOR POSSIBLE TREND FOR THIS SUBCLASS. BASED ON THIS CITI CUSTOMIZABLE SEARCH FOR THE SUBCLASSES OF ADVERSE EVENT/NEGLIGIBLE-MINOR FOR LBH PRODUCTS THE DATA DID NOT SHOW AN INCREASE OVER TIME (24 MONTHS). THERE IS NOT A TREND IDENTIFIED FOR THE SUBCLASS OF ADVERSE EVENT/NEGLIGIBLE-MINOR FOR LBH PRODUCT, REFER TO ATTACHMENT LBH ADVERSE EVENT NEGLIGIBLE-MINOR (B)(6) 2018 TO (B)(6) 2020. SITE SAMPLE STATUS WAS NOT RECEIVED. ACCORDING TO THE PRODUCT QUALITY COMPLAINT GROUP ON (B)(6) 2020: SUMMARY OF INVESTIGATION: BATCH AW2092 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: THE ROOT CAUSE CATEGORY IS NON ASSIGNABLE (COMPLAINT NOT CONFIRMED). AFTER A REVIEW OF THE BATCH THERMAL RECORDS, THERMAL RESULTS ALL MET PRODUCT RELEASE CRITERIA. CONSUMER REPORTS THE WRAP CAUSED, "BURNING MY SKIN". THE CAUSE OF THE CONSUMER STATING THE WRAP CAUSED "BURNING MY SKIN" IS INCONCLUSIVE SINCE REVIEW OF RECORDS DOES NOT PROVIDE EVIDENCE TO SUPPORT DEFECTIVE PRODUCT. THE PRODUCT EFFECT MAY VARY WITH EACH INDIVIDUAL. THE PLANT HAS REVIEWED THIS BATCH FROM A MANUFACTURING PERSPECTIVE. NO QUALITY ISSUES WERE IDENTIFIED UPON THIS REVIEW OF BATCH RECORDS, RELEASE TESTING DATA OR, INSPECTION OF RETAINED SAMPLES. RETAINED SAMPLES MET THE PRODUCT DESCRIPTION AND THE PRODUCT IS WITHIN EXPIRATION DATE. THE PRODUCT QUALITY FOR THE BATCH IS NOT IMPACTED BY THIS COMPLAINT.FOR THE BATCH. LOT TREND ASSESSMENT AND RATIONALE: AN EVALUATION OF THE COMPLAINT HISTORY CONFIRMS THAT THIS IS THE SECOND COMPLAINT FOR THE SUB CLASS ADVERSE EVENT/SERIOUS/UNKNOWN AT THE ALBANY SITE REQUIRING AN EVALUATION FOR THIS BATCH. THE PREVIOUS INVESTIGATION WAS NOT CONFIRMED TO HAVE A MANUFACTURING ROOT CAUSE RELATED TO THE SUBCLASS. PER (B)(4), COMPLAINT TRENDING GUIDELINE, EFFECTIVE (B)(6) 2020, A VISUAL EXAMINATION WAS PERFORMED TO IDENTIFY A POTENTIAL TREND FOR THE LOT AND SUBCLASS. A TREND WAS NOT IDENTIFIED. REFER TO CHART ON LOT TRENDING ATTACHMENT AW2092 ADVERSE EVENT SERIOUS UNKNOWN (1) . ON THE BASIS OF THIS EVALUATION, A TREND DOES NOT EXIST FOR THIS LOT. EXPEDITE TREND ASSESSMENT AND RATIONALE: A TREND DOES NOT EXIST FOR THIS BATCH. SITE SAMPLE STATUS WAS NOT RECEIVED. ACCORDING TO THE PRODUCT QUALITY COMPLAINT GROUP ON (B)(6) 2020: SUMMARY OF INVESTIGATION: BATCH AW2092 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: THE ROOT CAUSE CATEGORY IS NON-ASSIGNABLE (COMPLAINT NOT CONFIRMED AS A QUALITY DEFECT). A RETURN SAMPLE HAS NOT BEEN RECEIVED AT THE SITE FOR EVALUATION, THE COMPLAINT CANNOT BE CONFIRMED. THE PLANT HAS REVIEWED THIS BATCH FROM A MANUFACTURING PERSPECTIVE. NO QUALITY ISSUES WERE IDENTIFIED UPON THIS REVIEW OF BATCH RECORDS, RELEASE TESTING DATA OR, INSPECTION OF RETAINED SAMPLES. RETAINED SAMPLES MET THE PRODUCT DESCRIPTION AND THE PRODUCT IS WITHIN EXPIRATION DATE. THE PRODUCT QUALITY FOR THE BATCH IS NOT IMPACTED BY THIS COMPLAINT. PROCESS RELATED WAS NO. FINAL CONFIRMATION STATUS WAS NOT CONFIRMED. LOT TREND ASSESSMENT AND RATIONALE: AN EVALUATION OF THE COMPLAINT HISTORY CONFIRMS THAT THIS IS THE FIRST COMPLAINT FOR THE SUB CLASS INCORRECT/MISSING/ILLEGIBLE TEXT (EXCEPT LOT/EXP/BATCH INFO) RECEIVED AT THE ALBANY,GA SITE FOR THIS BATCH. ON THE BASIS OF THIS EVALUATION, A TREND DOES NOT EXIST FOR THIS LOT. NO EXPEDITE TREND WAS IDENTIFIED. EXPEDITE TREND ASSESSMENT AND RATIONALE: THIS IS NOT AN EXPEDITE COMPLAINT. SITE SAMPLE STATUS WAS NOT RECEIVED. FOLLOW-UP (15SEP2020): NEW INFORMATION RECEIVED FROM THE PRODUCT QUALITY COMPLAINT GROUP INCLUDES INVESTIGATIONAL RESULTS. FOLLOW-UP (21SEP2020): NEW INFORMATION RECEIVED FROM THE PRODUCT QUALITY COMPLAINT GROUP INCLUDES INVESTIGATIONAL RESULTS. FOLLOW-UP (13OCT2020): FOLLOW-UP ATTEMPTS COMPLETED. NO FURTHER INFORMATION IS EXPECTED. FOLLOW UP (15OCT2020): NEW INFORMATION RECEIVED FROM THE PRODUCT QUALITY COMPLAINT GROUP INCLUDES INVESTIGATIONAL RESULTS.

    Description of Event or Problem · 0

    EVENT VERBATIM [PREFERRED TERM]. HAD 1ST DEGREE BURN IN THE LOCATION HE PLACED THE WRAP/THE AREA THAT GOT BURNED IS EXACTLY WHERE HE PUT IT. IT IS LIKE ALL RED/HE WAS BURNING AND HURTING [APPLICATION SITE BURN], HE WAS NOT SURE IF THIS OCCURRED BECAUSE IT WAS DEFECTIVE OR WHAT [DEVICE ISSUE], , NARRATIVE: THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER (PATIENT). A 51-YEAR-OLD MALE PATIENT STARTED TO USE THERMACARE HEATWRAP (ROBAX LOWER BACK & HIP HEATWRAP), DEVICE LOT NUMBER AW2092, EXPIRATION DATE APR2022, CATALOG # 0 62107 33630 7, DATE OF MANUFACTURE: 23MAY2019 TO 26MAY2019, FROM AN UNSPECIFIED DATE AT AN UNSPECIFIED FREQUENCY FOR BACK PAIN. THE PATIENT MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PATIENT STATED HE USED ROBAX HEATWRAPS ON HIS BACK PAIN AND HE ENDED UP BY BURNING HIS SKIN. HE ASKED IF IT WAS DEFECTIVE OR WHAT. THE PATIENT STATED HE PURCHASED A BOX BECAUSE HE HAD BACK PAIN. HE STATED HE DID NOT SEE A MANUFACTURER NAME LISTED TO PROVIDE. IT CAME WITH 3 HEATWRAPS INSIDE THE BOX. HE USED ONE AND THEN HE TRIED A SECOND ONE AND HAD 1ST DEGREE BURN IN THE LOCATION HE PLACED THE WRAP. THIS OCCURRED TEN DAYS AGO ON 23AUG2020. HE STATED HE WENT TO A WALK IN EMERGENCY TYPE CLINIC PLACE. HE INITIALLY WENT THERE FOR THE BACK PAIN AND THAT WAS WHEN HE REALIZED HE HAD AN ACTUAL BURN AND THE DOCTOR TOLD HIM TO CALL AND REPORT THIS. HE WAS TOLD HE HAD A 1ST DEGREE BURN. TREATMENT: TOLD TO PLACE A COLD BAG, LIKE ICE BAG TO COOL IT DOWN. HE WAS ALSO TAKING PILLS FOR THE BACK PAIN HE ALREADY HAD. THIS WAS FOR THE LOWER BACK. HE WAS NOT SURE IF THIS OCCURRED BECAUSE IT WAS DEFECTIVE OR WHAT, CLARIFYING THE AREA THAT GOT BURNED WAS EXACTLY WHERE HE PUT IT. IT WAS LIKE ALL RED. THE BURN HE SAID HE CAN LIVE WITH. HE DID NOT THINK IT WOULD LEAVE A MARK OR ANYTHING. AFTER THE LOT NUMBER SEES 05/25. HE EXPLAINED AFTER APPLYING THIS SECOND HEAT WRAP WHICH CAUSED THE BURN HE DID NOT REALIZE HE FELT A BURNING SENSATION UNTIL 2-3 HOURS AFTER IT WAS ON. HE WAS NOT REALLY PAYING ATTENTION TO IT BECAUSE HE ALREADY HAD BACK PAIN. HE HAD ALREADY HURT HIS BACK PULLING SOMETHING. AT THE TIME HE WAS NOT TAKING ANY OTHER MEDICATION, BUT NOW HE WAS TAKING MEDICATION FOR BACK PAIN. HE HAD GONE TO THE PHARMACY INITIALLY TO TRY AND TREAT THE BACK PAIN HE WAS HAVING HIMSELF. HOWEVER, AFTER APPLYING THE HEATWRAP HE REALIZED HE WAS BURNING AND HURTING SO HE WENT TO THE WALK IN CLINIC AND WAS TREATED. HE TOOK PICTURES OF HOW THE BURN AREA LOOKED. HE NO LONGER HAD THE HEATWRAP THAT CAUSED THE BURN. HE THREW IT AWAY IN THE GARBAGE. HE STILL HAD THE THIRD HEATWRAP THAT WAS IN THE BOX THAT WAS CLOSED. HE WASN'T REALLY CORRELATING ANYTHING TO THE HEATWRAP IN THE BEGINNING. HE WAS WORRYING MORE ABOUT HIS HURT BACK THAN A BURN. THE ACTION TAKEN IN RESPONSE TO THE EVENTS FOR THE PRODUCT WAS UNKNOWN. THE EVENTS OUTCOME WAS RECOVERING. ACCORDING TO THE PRODUCT QUALITY COMPLAINT GROUP ON 15SEP2020: SUMMARY OF INVESTIGATION: BATCH AW2092 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. LOT TREND ASSESSMENT AND RATIONALE: AN EVALUATION OF THE COMPLAINT HISTORY CONFIRMS THAT THIS IS THE SECOND COMPLAINT FOR THE SUB CLASS ADVERSE EVENT/NEGLIGIBLE MINOR RECEIVED AT THE ALBANY SITE REQUIRING AN EVALUATION FOR THIS BATCH. ON THE BASIS OF THIS EVALUATION, A TREND DOES NOT EXIST FOR THIS LOT. EXPEDITE TREND ASSESSMENT AND RATIONALE: AN EVALUATION WAS MADE BY SEARCHING FOR POSSIBLE TREND FOR THIS SUBCLASS. BASED ON THIS CITI CUSTOMIZABLE SEARCH FOR THE SUBCLASSES OF ADVERSE EVENT/NEGLIGIBLE-MINOR FOR LBH PRODUCTS THE DATA DID NOT SHOW AN INCREASE OVER TIME (24 MONTHS). THERE IS NOT A TREND IDENTIFIED FOR THE SUBCLASS OF ADVERSE EVENT/NEGLIGIBLE-MINOR FOR LBH PRODUCT, REFER TO ATTACHMENT LBH ADVERSE EVENT NEGLIGIBLE-MINOR 01-SEP-2018 TO 01-SEP-2020. CONCLUSION: 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, ''1ST DEGREE BURN''. THE CAUSE OF THE CONSUMER STATING THE WRAP CAUSED 1ST DEGREE BURN IS INCONCLUSIVE SINCE REVIEW OF RECORDS DOES NOT PROVIDE EVIDENCE TO SUPPORT DEFECTIVE PRODUCT. THE PRODUCT EFFECT MAY VARY WITH EACH INDIVIDUAL. THE PLANT HAS REVIEWED THIS BATCH FROM A MANUFACTURING PERSPECTIVE. NO QUALITY ISSUES WERE IDENTIFIED UPON THIS REVIEW OF BATCH RECORDS, RELEASE TESTING DATA OR, INSPECTION OF RETAINED SAMPLES. RETAINED SAMPLES MET THE PRODUCT DESCRIPTION AND THE PRODUCT IS WITHIN EXPIRATION DATE. THE PRODUCT QUALITY FOR THE BATCH IS NOT IMPACTED BY THIS COMPLAINT. ROOT CAUSE/CAPA: PROCESS RELATED WAS NO. FINAL CONFIRMATION STATUS WAS NOT CONFIRMED. SITE SAMPLE STATUS WAS NOT RECEIVED. ACCORDING TO THE PRODUCT QUALITY COMPLAINT GROUP ON 21SEP2020: SITE SAMPLE STATUS: NOT RECEIVED. SUMMARY OF INVESTIGATION: BATCH AW2092 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: THE ROOT CAUSE CATEGORY IS NON ASSIGNABLE (COMPLAINT NOT CONFIRMED). AFTER A REVIEW OF THE BATCH THERMAL RECORDS, THERMAL RESULTS ALL MET PRODUCT RELEASE CRITERIA. CONSUMER REPORTS THE WRAP CAUSED, "BURNING MY SKIN". THE CAUSE OF THE CONSUMER STATING THE WRAP CAUSED "BURNING MY SKIN" IS INCONCLUSIVE SINCE REVIEW OF RECORDS DOES NOT PROVIDE EVIDENCE TO SUPPORT DEFECTIVE PRODUCT. THE PRODUCT EFFECT MAY VARY WITH EACH INDIVIDUAL. THE PLANT HAS REVIEWED THIS BATCH FROM A MANUFACTURING PERSPECTIVE. NO QUALITY ISSUES WERE IDENTIFIED UPON THIS REVIEW OF BATCH RECORDS, RELEASE TESTING DATA OR, INSPECTION OF RETAINED SAMPLES. RETAINED SAMPLES MET THE PRODUCT DESCRIPTION AND THE PRODUCT IS WITHIN EXPIRATION DATE. THE PRODUCT QUALITY FOR THE BATCH IS NOT IMPACTED BY THIS COMPLAINT.FOR THE BATCH. LOT TREND ASSMT. & RATIONALE: AN EVALUATION OF THE COMPLAINT HISTORY CONFIRMS THAT THIS IS THE SECOND COMPLAINT FOR THE SUB CLASS ADVERSE EVENT/SERIOUS/UNKNOWN AT THE ALBANY SITE REQUIRING AN EVALUATION FOR THIS BATCH. THE PREVIOUS INVESTIGATION WAS NOT CONFIRMED TO HAVE A MANUFACTURING ROOT CAUSE RELATED TO THE SUBCLASS. PER SOP 105746, COMPLAINT TRENDING GUIDELINE, EFFECTIVE 24FEB2020, A VISUAL EXAMINATION WAS PERFORMED TO IDENTIFY A POTENTIAL TREND FOR THE LOT AND SUBCLASS. A TREND WAS NOT IDENTIFIED. REFER TO CHART ON LOT TRENDING ATTACHMENT AW2092 ADVERSE EVENT SERIOUS UNKNOWN (1) . ON THE BASIS OF THIS EVALUATION, A TREND DOES NOT EXIST FOR THIS LOT. EXPED TREND ASSMT. & RATIONALE: A TREND DOES NOT EXIST FOR THIS BATCH. SITE SAMPLE STATUS: NOT RECEIVED. FOLLOW-UP (15SEP2020): NEW INFORMATION RECEIVED FROM THE PRODUCT QUALITY COMPLAINT GROUP INCLUDES INVESTIGATIONAL RESULTS. FOLLOW-UP (21SEP2020): NEW INFORMATION RECEIVED FROM THE PRODUCT QUALITY COMPLAINT GROUP INCLUDES INVESTIGATIONAL RESULTS.

    Description of Event or Problem · 0

    EVENT VERBATIM [PREFERRED TERM]: HAD 1ST DEGREE BURN IN THE LOCATION HE PLACED THE WRAP/THE AREA THAT GOT BURNED IS EXACTLY WHERE HE PUT IT. IT IS LIKE ALL RED/HE WAS BURNING AND HURTING [APPLICATION SITE BURN], HE WAS NOT SURE IF THIS OCCURRED BECAUSE IT WAS DEFECTIVE OR WHAT [DEVICE ISSUE], NARRATIVE: THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER (PATIENT). A 51-YEAR-OLD MALE PATIENT STARTED TO USE THERMACARE HEATWRAP (ROBAX LOWER BACK & HIP HEATWRAP), DEVICE LOT NUMBER AW2092, EXPIRATION DATE APR2022, CATALOG # 0 62107 33630 7, FROM AN UNSPECIFIED DATE AT AN UNSPECIFIED FREQUENCY FOR BACK PAIN. THE PATIENT MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PATIENT STATED HE USED ROBAX HEATWRAPS ON HIS BACK PAIN AND HE ENDED UP BY BURNING HIS SKIN. HE ASKED IF IT WAS DEFECTIVE OR WHAT. THE PATIENT STATED HE PURCHASED A BOX BECAUSE HE HAD BACK PAIN. HE STATED HE DID NOT SEE A MANUFACTURER NAME LISTED TO PROVIDE. IT CAME WITH 3 HEATWRAPS INSIDE THE BOX. HE USED ONE AND THEN HE TRIED A SECOND ONE AND HAD 1ST DEGREE BURN IN THE LOCATION HE PLACED THE WRAP. THIS OCCURRED TEN DAYS AGO ON (B)(6) 2020. HE STATED HE WENT TO A WALK IN EMERGENCY TYPE CLINIC PLACE. HE INITIALLY WENT THERE FOR THE BACK PAIN AND THAT WAS WHEN HE REALIZED HE HAD AN ACTUAL BURN AND THE DOCTOR TOLD HIM TO CALL AND REPORT THIS. HE WAS TOLD HE HAD A 1ST DEGREE BURN. TREATMENT: TOLD TO PLACE A COLD BAG, LIKE ICE BAG TO COOL IT DOWN. HE WAS ALSO TAKING PILLS FOR THE BACK PAIN HE ALREADY HAD. THIS WAS FOR THE LOWER BACK. HE WAS NOT SURE IF THIS OCCURRED BECAUSE IT WAS DEFECTIVE OR WHAT, CLARIFYING THE AREA THAT GOT BURNED WAS EXACTLY WHERE HE PUT IT. IT WAS LIKE ALL RED. THE BURN HE SAID HE CAN LIVE WITH. HE DID NOT THINK IT WOULD LEAVE A MARK OR ANYTHING. AFTER THE LOT NUMBER SEES (B)(6). HE EXPLAINED AFTER APPLYING THIS SECOND HEAT WRAP WHICH CAUSED THE BURN HE DID NOT REALIZE HE FELT A BURNING SENSATION UNTIL 2-3 HOURS AFTER IT WAS ON. HE WAS NOT REALLY PAYING ATTENTION TO IT BECAUSE HE ALREADY HAD BACK PAIN. HE HAD ALREADY HURT HIS BACK PULLING SOMETHING. AT THE TIME HE WAS NOT TAKING ANY OTHER MEDICATION, BUT NOW HE WAS TAKING MEDICATION FOR BACK PAIN. HE HAD GONE TO THE PHARMACY INITIALLY TO TRY AND TREAT THE BACK PAIN HE WAS HAVING HIMSELF. HOWEVER, AFTER APPLYING THE HEATWRAP HE REALIZED HE WAS BURNING AND HURTING SO HE WENT TO THE WALK IN CLINIC AND WAS TREATED. HE TOOK PICTURES OF HOW THE BURN AREA LOOKED. HE NO LONGER HAD THE HEATWRAP THAT CAUSED THE BURN. HE THREW IT AWAY IN THE GARBAGE. HE STILL HAD THE THIRD HEATWRAP THAT WAS IN THE BOX THAT WAS CLOSED. HE WASN'T REALLY CORRELATING ANYTHING TO THE HEATWRAP IN THE BEGINNING. HE WAS WORRYING MORE ABOUT HIS HURT BACK THAN A BURN. THE ACTION TAKEN IN RESPONSE TO THE EVENTS FOR THE PRODUCT WAS UNKNOWN. THE EVENTS OUTCOME WAS RECOVERING. ACCORDING TO THE PRODUCT QUALITY COMPLAINT GROUP: SUMMARY OF INVESTIGATION: BATCH AW2092 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. LOT TREND ASSESSMENT AND RATIONALE: AN EVALUATION OF THE COMPLAINT HISTORY CONFIRMS THAT THIS IS THE SECOND COMPLAINT FOR THE SUB CLASS ADVERSE EVENT/NEGLIGIBLE MINOR RECEIVED AT THE ALBANY SITE REQUIRING AN EVALUATION FOR THIS BATCH. ON THE BASIS OF THIS EVALUATION, A TREND DOES NOT EXIST FOR THIS LOT. EXPEDITE TREND ASSESSMENT AND RATIONALE: AN EVALUATION WAS MADE BY SEARCHING FOR POSSIBLE TREND FOR THIS SUBCLASS. BASED ON THIS CITI CUSTOMIZABLE SEARCH FOR THE SUBCLASSES OF ADVERSE EVENT/NEGLIGIBLE-MINOR FOR LBH PRODUCTS THE DATA DID NOT SHOW AN INCREASE OVER TIME (24 MONTHS). THERE IS NOT A TREND IDENTIFIED FOR THE SUBCLASS OF ADVERSE EVENT/NEGLIGIBLE-MINOR FOR LBH PRODUCT, REFER TO ATTACHMENT LBH ADVERSE EVENT NEGLIGIBLE-MINOR (B)(6) 2018 TO (B)(6) 2020. CONCLUSION: 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, ''1ST DEGREE BURN''. THE CAUSE OF THE CONSUMER STATING THE WRAP CAUSED 1ST DEGREE BURN IS INCONCLUSIVE SINCE REVIEW OF RECORDS DOES NOT PROVIDE EVIDENCE TO SUPPORT DEFECTIVE PRODUCT. THE PRODUCT EFFECT MAY VARY WITH EACH INDIVIDUAL. THE PLANT HAS REVIEWED THIS BATCH FROM A MANUFACTURING PERSPECTIVE. NO QUALITY ISSUES WERE IDENTIFIED UPON THIS REVIEW OF BATCH RECORDS, RELEASE TESTING DATA OR, INSPECTION OF RETAINED SAMPLES. RETAINED SAMPLES MET THE PRODUCT DESCRIPTION AND THE PRODUCT IS WITHIN EXPIRATION DATE. THE PRODUCT QUALITY FOR THE BATCH IS NOT IMPACTED BY THIS COMPLAINT. ROOT CAUSE/CAPA: PROCESS RELATED WAS NO. FINAL CONFIRMATION STATUS WAS NOT CONFIRMED. SITE SAMPLE STATUS WAS NOT RECEIVED. FOLLOW-UP (15SEP2020): NEW INFORMATION RECEIVED FROM THE PRODUCT QUALITY COMPLAINT GROUP INCLUDES INVESTIGATIONAL RESULTS.

    Description of Event or Problem · 1

    HAD 1ST DEGREE BURN IN THE LOCATION HE PLACED THE WRAP/THE AREA THAT GOT BURNED IS EXACTLY WHERE HE PUT IT. IT IS LIKE ALL RED/HE WAS BURNING AND HURTING [APPLICATION SITE BURN]. HE WAS NOT SURE IF THIS OCCURRED BECAUSE IT WAS DEFECTIVE OR WHAT [DEVICE ISSUE]. NARRATIVE: THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER (PATIENT). A (B)(6) MALE PATIENT STARTED TO USE THERMACARE HEATWRAP (ROBAX LOWER BACK & HIP HEATWRAP), DEVICE LOT NUMBER AW2092, EXPIRATION DATE APR2022, FROM AN UNSPECIFIED DATE AT AN UNSPECIFIED FREQUENCY FOR BACK PAIN. THE PATIENT MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PATIENT STATED HE USED ROBAX HEATWRAPS ON HIS BACK PAIN AND HE ENDED UP BY BURNING HIS SKIN. HE ASKED IF IT WAS DEFECTIVE OR WHAT. THE PATIENT STATED HE PURCHASED A BOX BECAUSE HE HAD BACK PAIN. HE STATED HE DID NOT SEE A MANUFACTURER NAME LISTED TO PROVIDE. IT CAME WITH 3 HEATWRAPS INSIDE THE BOX. HE USED ONE AND THEN HE TRIED A SECOND ONE AND HAD 1ST DEGREE BURN IN THE LOCATION HE PLACED THE WRAP. THIS OCCURRED TEN DAYS AGO ON (B)(6) 2020. HE STATED HE WENT TO A WALK IN EMERGENCY TYPE CLINIC PLACE. HE INITIALLY WENT THERE FOR THE BACK PAIN AND THAT WAS WHEN HE REALIZED HE HAD AN ACTUAL BURN AND THE DOCTOR TOLD HIM TO CALL AND REPORT THIS. HE WAS TOLD HE HAD A 1ST DEGREE BURN. TREATMENT: TOLD TO PLACE A COLD BAG, LIKE ICE BAG TO COOL IT DOWN. HE WAS ALSO TAKING PILLS FOR THE BACK PAIN HE ALREADY HAD. THIS WAS FOR THE LOWER BACK. HE WAS NOT SURE IF THIS OCCURRED BECAUSE IT WAS DEFECTIVE OR WHAT, CLARIFYING THE AREA THAT GOT BURNED WAS EXACTLY WHERE HE PUT IT. IT WAS LIKE ALL RED. THE BURN HE SAID HE CAN LIVE WITH. HE DID NOT THINK IT WOULD LEAVE A MARK OR ANYTHING. AFTER THE LOT NUMBER SEES 05/25. HE EXPLAINED AFTER APPLYING THIS SECOND HEAT WRAP WHICH CAUSED THE BURN HE DID NOT REALIZE HE FELT A BURNING SENSATION UNTIL 2-3 HOURS AFTER IT WAS ON. HE WAS NOT REALLY PAYING ATTENTION TO IT BECAUSE HE ALREADY HAD BACK PAIN. HE HAD ALREADY HURT HIS BACK PULLING SOMETHING. AT THE TIME HE WAS NOT TAKING ANY OTHER MEDICATION, BUT NOW HE WAS TAKING MEDICATION FOR BACK PAIN. HE HAD GONE TO THE PHARMACY INITIALLY TO TRY AND TREAT THE BACK PAIN HE WAS HAVING HIMSELF. HOWEVER, AFTER APPLYING THE HEATWRAP HE REALIZED HE WAS BURNING AND HURTING SO HE WENT TO THE WALK IN CLINIC AND WAS TREATED. HE TOOK PICTURES OF HOW THE BURN AREA LOOKED. HE NO LONGER HAD THE HEATWRAP THAT CAUSED THE BURN. HE THREW IT AWAY IN THE GARBAGE. HE STILL HAD THE THIRD HEATWRAP THAT WAS IN THE BOX THAT WAS CLOSED. HE WASN'T REALLY CORRELATING ANYTHING TO THE HEATWRAP IN THE BEGINNING. HE WAS WORRYING MORE ABOUT HIS HURT BACK THAN A BURN. THE ACTION TAKEN IN RESPONSE TO THE EVENT FOR THE PRODUCT WAS UNKNOWN. THE EVENT OUTCOME WAS RECOVERING. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE PROVIDED AS IT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    966206 ROBAX LOWER BACK & HIP HEATWRAP DISPOSABLE PACK, HOT IMD PFIZER CONSUMER HEALTHCARE (CANADA) AW2092

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention