THERMACARE LOWER BACK & HIP
Report
- Report Number
- 1066015-2018-00160
- Event Type
- Injury
- Date Received
- November 19, 2018
- Date of Event
- November 4, 2018
- Report Date
- November 5, 2018
- Manufacturer
- PFIZER CONSUMER HEALTH CARE
- Product Code
- IMD
- PMA / PMN Number
- K953442
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
ON 18SEP2020: PRODUCT: THERMACARE LOWER BACK & HIP. LOT NUMBER AND EXPIRATION DATE: W91247 AND MAY2021. DESCRIPTION OF COMPLIANT: THE BURN WAS LOCATED ON HER LOWER BACK. ON THE RIGHT SIDE OF HER LOWER BACK, THE BURN HAD BROKEN THE SKIN BUT IT DID NOT ON LEFT SIDE. THE BURN COULD BE SEEN ON BOTH SIDES THOUGH. REASONABLY SUGGEST DEVICE MALFUNCTION: NO. SEVERITY OF HARM: N/A. SITE SAMPLE STATUS: RECEIVED AT THE SITE ON 10DEC2018. SUMMARY OF INVESTIGATION: THIS INVESTIGATION WAS PREVIOUSLY CLOSED IN LEGACY COMPLAINT INVESTIGATION MODULE. THE INVESTIGATION WAS REOPENED TO ADD THE CONSUMER RETURNED SAMPLE EVALUATION RESULTS TO THE INVESTIGATION. THE EVALUATION RESULTS DID NOT CHANGE THE ROOT CAUSE OF THE COMPLAINT. ROOT CAUSE CAPA: ROOT CAUSE CATEGORY: NON-ASSIGNABLE (COMPLAINT NOT CONFIRMED). PROCESS RELATED?: NO. FINAL CONFIRMATION STATUS: NOT CONFIRMED. RETURN SAMPLE EVALUATION: ONE LBH WRAP - WRAP SHOWS EVIDENCE OF WEAR. CELL PACKS ARE HARD; EVIDENCE OF BRINE DOSING, CELL PACKS ARE INTACT. ONE LBH POUCH - POUCH IS OPEN. ONE LBH CARTON - CARTON IS OPEN. CONFIRMED COMPLAINT SAMPLE DEFECT?: NO.
EVENT VERBATIM [PREFERRED TERM], SHE DID NOT CHECK HER SKIN UNDER THE PRODUCT WHILE WEARING THERMACARE [INTENTIONAL DEVICE MISUSE], USED THE PRODUCT FOR 1 DAY FOR 10 HOURS A DAY [INTENTIONAL DEVICE USE ISSUE], BURN WAS LOCATED ON HER LOWER BACK/ON LEFT SIDE [THERMAL BURN], BURN WAS LOCATED ON HER LOWER BACK/ON THE RIGHT SIDE IT BROKE THE SKIN [BURNS SECOND DEGREE], SCAR [SCAR], NARRATIVE: THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER REPORTING FOR HERSELF. A 41-YEAR-OLD FEMALE PATIENT STARTED TO RECEIVE THERMACARE HEATWRAP (THERMACARE LOWER BACK & HIP) (2 COUNT (RED) BOX X LARGE SIZE, DEVICE LOT NUMBER W91247, EXPIRATION DATE MAY2021, UPC NUMBER (B)(4)) ON (B)(6) 2018 FOR LOWER BACK PAIN. THE PATIENT'S MEDICAL HISTORY INCLUDED BACK PAIN (HAD BEEN TO THE HOSPITAL FOR A CORTISONE SHOT IN HER BACK). THE PATIENT WAS NOT PREGNANT AND NOT POST-MENOPAUSAL. THERE WERE NO CONCOMITANT MEDICATIONS. THE PATIENT PREVIOUSLY USED THERMACARE HEATWRAPS 3 PACK FOR OVER A YEAR (2017) BUT STATED IT DIDN'T REALLY HOLD OR STAY ON HER VERY WELL AS SHE WAS A BIGGER WOMAN (UPC, UDI, LOT, OR EXPIRY WAS UNKNOWN). THIS WAS WHY SHE DECIDED TO GO UP TO THE 2 PACK WHICH WAS THE EXTRA LARGE SIZE. IN THE PAST, SHE HAD BEEN TO THE HOSPITAL FOR A CORTISONE SHOT FOR BACK PAIN. SHE WENT MONTHS WITHOUT USING THE PRODUCT BUT WHEN THE SHOT WORE OFF, SHE HAD RETURNED TO USING JUST THE THERMACARE 2 PACK EXTRA LARGE SIZE. THE PATIENT REPORTED SHE LAST WORE THE PRODUCT WHILE AT WORK. IT WAS PUT ON AROUND 9:00 AM AND REMOVED AROUND 7:00 PM ON (B)(6) 2018. SHE USED THE PRODUCT FOR 1 DAY FOR 10 HOURS. WHEN SHE RETURNED HOME, SHE TOOK IT OFF THEN WENT TO SLEEP. THE BURN WAS NOT NOTICED UNTIL THE FOLLOWING MORNING, (B)(6) 2018, WHEN SHE WENT TO REAPPLY A NEW WRAP. SHE REPORTED THE BURN WAS LOCATED ON HER LOWER BACK. ON THE RIGHT SIDE OF HER LOWER BACK, THE BURN HAD BROKEN THE SKIN BUT IT DID NOT ON LEFT SIDE. THE BURN COULD BE SEEN ON BOTH SIDES THOUGH. SHE NOTICED THE SKIN WAS BROKEN BECAUSE SHE RUBBED IT AND IT HURT. THE PATIENT DID NOT CONSULT A HEALTHCARE PROFESSIONAL FOR THE PROBLEMS OR SYMPTOMS. SHE STATED THIS WAS NOT A BURN SHE WOULD HAVE TO GO TO HOSPITAL FOR OR SEEK MEDICAL TREATMENT BUT IT DID BREAK THE SKIN. NO HOSPITALIZATION WAS REQUIRED AS A RESULT OF THE BURN. THE BURN WAS LOCATED WHERE THE HEATWRAP WAS APPLIED. SHE ASKED HER MOTHER IF THERE WAS SOMETHING WRONG WITH HER BACK AND HER MOTHER TOLD HER SHE HAD A BURN. THE PATIENT TREATED THE BURN WITH DISINFECTANT, A&D OINTMENT AND GAUZE TO COVER THE AREA. THE SYMPTOMS LASTED APPROXIMATELY 2 WEEKS AND A SCAR REMAINED FROM AN UNSPECIFIED DATE IN (B)(6) 2018. SHE WAS NOT UNDER THE CARE OF A PHYSICIAN FOR ANY MEDICAL CONDITIONS. THE PATIENT ASSESSED HER SKIN TONE AS MEDIUM (BROWN), NEITHER LIGHT NOR DARK. SHE DENIED HAVING SENSITIVE SKIN AND DID NOT HAVE ANY ABNORMAL SKIN CONDITIONS. THE PATIENT DENIED USING OTHER HEAT PRODUCTS FOR PAIN RELIEF (ELECTRIC HEATING PAD, HOT WATER BOTTLE, MICROWAVE GEL PACK). THE PATIENT WAS WEARING A TANK TOP AND SHIRT OVER THE PRODUCT AND THE PRODUCT WAS THE ONE THAT SECURES WITH VELCRO, NO ADHESIVE. SHE DID NOT ENGAGE IN EXERCISE WHILE USING THE PRODUCT. SHE DID NOT CHECK HER SKIN UNDER THE PRODUCT WHILE WEARING THERMACARE ON (B)(6) 2018. SHE DID READ THE USAGE INSTRUCTIONS ON THERMACARE BEFORE USING THE HEATWRAP. THE ACTION TAKEN IN RESPONSE TO THE EVENTS WAS PERMANENTLY WITHDRAWN ON (B)(6) 2018. THE OUTCOME OF THE EVENTS "BURN WAS LOCATED ON HER LOWER BACK/ON THE RIGHT SIDE IT BROKE THE SKIN" AND "BURN WAS LOCATED ON HER LOWER BACK/ON LEFT SIDE" WAS RESOLVED WITH SEQUELAE IN (B)(6) 2018. THE OUTCOME OF THE REMAINING EVENTS WAS UNKNOWN. THE PATIENT REPORTED A SAMPLE OF THE PRODUCT WAS AVAILABLE TO BE RETURNED. THE PATIENT REMARKED THE BURN WAS CAUSED BY A MALFUNCTION OF THE DEVICE. ON (B)(6) 2018, ACCORDING TO THE PRODUCT QUALITY COMPLAINT GROUP: 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 THERE IS "A BURN WHERE THE PRODUCT WAS". THE CAUSE OF THE BURN IS INCONCLUSIVE SINCE REVIEW OF RECORDS DOES NOT PROVIDE EVIDENCE TO SUPPORT DEFECTIVE PRODUCT. THE PRODUCT EFFECT MAY VARY WITH EACH INDIVIDUAL. THE CONSUMER RETURNED SAMPLE HAS NOT BEEN RECEIVED AT THE SITE FOR EVALUATION AS OF 13DEC2018. 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. ON 18SEP2020, THE PRODUCT QUALITY COMPLAINT GROUP PROVIDED THE FOLLOWING INVESTIGATION RESULTS THAT YIELDED NO PRODUCT QUALITY ISSUES. PRODUCT: THERMACARE LOWER BACK & HIP. LOT NUMBER AND EXPIRATION DATE: W91247 AND MAY2021. DESCRIPTION OF COMPLIANT: THE BURN WAS LOCATED ON HER LOWER BACK. ON THE RIGHT SIDE OF HER LOWER BACK, THE BURN HAD BROKEN THE SKIN BUT IT DID NOT ON LEFT SIDE. THE BURN COULD BE SEEN ON BOTH SIDES THOUGH. REASONABLY SUGGEST DEVICE MALFUNCTION: NO. SEVERITY OF HARM: N/A. SITE SAMPLE STATUS: RECEIVED AT THE SITE ON 10DEC2018. SUMMARY OF INVESTIGATION: THIS INVESTIGATION WAS PREVIOUSLY CLOSED IN LEGACY COMPLAINT INVESTIGATION MODULE. THE INVESTIGATION WAS REOPENED TO ADD THE CONSUMER RETURNED SAMPLE EVALUATION RESULTS TO THE INVESTIGATION. THE EVALUATION RESULTS DID NOT CHANGE THE ROOT CAUSE OF THE COMPLAINT. ROOT CAUSE CAPA: ROOT CAUSE CATEGORY: NON-ASSIGNABLE (COMPLAINT NOT CONFIRMED). PROCESS RELATED?: NO. FINAL CONFIRMATION STATUS: NOT CONFIRMED. RETURN SAMPLE EVALUATION: ONE LBH WRAP - WRAP SHOWS EVIDENCE OF WEAR. CELL PACKS ARE HARD; EVIDENCE OF BRINE DOSING, CELL PACKS ARE INTACT. ONE LBH POUCH - POUCH IS OPEN. ONE LBH CARTON - CARTON IS OPEN. CONFIRMED COMPLAINT SAMPLE DEFECT?: NO. FOLLOW-UP (11DEC2018): NEW INFORMATION RECEIVED FROM A CONTACTABLE CONSUMER INCLUDES: PATIENT DETAILS, UPDATED ACTION TAKEN WITH SUSPECT PRODUCT, REACTION DATA (ADDITIONAL EVENT SCAR), EVENTS OUTCOME, EVENTS STOP DATE, AND NO HOSPITALIZATION REQUIRED. FOLLOW UP ATTEMPTS ARE COMPLETED. NO FURTHER INFORMATION IS EXPECTED. AMENDMENT: THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO AMEND PREVIOUSLY REPORTED INFORMATION: UPDATED OUTCOME OF EVENTS BURN AND BURN BLISTER FROM NOT RECOVERED TO RECOVERED WITH SEQUELAE. FOLLOW-UP (17DEC2018): THIS IS A FOLLOW-UP REPORT FROM THE PRODUCT QUALITY COMPLAINT GROUP INCLUDES INVESTIGATIONAL RESULTS, ONSET DATE OF EVENTS AND EVENT ASSESSMENT. FOLLOW-UP ATTEMPTS ARE COMPLETED. NO FURTHER INFORMATION IS EXPECTED. FOLLOW-UP (18SEP2020): NEW INFORMATION RECEIVED FROM THE PRODUCT QUALITY COMPLAINT GROUP INCLUDED: INVESTIGATION RESULTS THAT YIELDED NO PRODUCT QUALITY ISSUES. FOLLOW-UP ATTEMPTS ARE COMPLETED. NO FURTHER INFORMATION IS EXPECTED. COMMENT: BASED ON THE INFORMATION PROVIDED, THE EVENTS BURNS SECOND DEGREE, THERMAL BURN AND INTENTIONAL DEVICE MISUSE AS DESCRIBED ARE CONSIDERED SERIOUS BODILY INJURY REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT DAMAGE OR IMPAIRMENT OF BODY STRUCTURE. THE EVENT INTENTIONAL DEVICE USE ISSUE AND SCAR ARE ASSESSED AS NON-SERIOUS. THE EVENTS ARE MEDICALLY ASSESSED AS ASSOCIATED WITH THE USE OF THE DEVICE. THE REVIEW OF THE LOT/BATCH RECORDS DOES NOT SUGGEST A DEFECT OR QUALITY ISSUE RELATED TO THE MANUFACTURE OF THIS LOT. NO DEVICE MALFUNCTION HAS BEEN IDENTIFIED. IN THE CASE NARRATIVE THERE IS EVIDENCE OF INTENTIONAL DEVICE MISUSE WHICH MOST LIKELY CONTRIBUTED TO THIS INCIDENT. NO REMEDIAL ACTION/CORRECTIVE ACTION/FIELD SAFETY CORRECTIVE ACTION IS SUGGESTED AT THIS TIME.
EVENT [PREFERRED TERM] BURN IS LOCATED ON HER LOWER BACK; ON THE RIGHT SIDE IT BROKE THE SKIN/I WAS BURNED ON MY BACK [BURNS SECOND DEGREE] , BURN IS LOCATED ON HER LOWER BACK ON LEFT SIDE/I WAS BURNED ON MY BACK [THERMAL BURN] , SHE DID NOT CHECK HER SKIN UNDER THE PRODUCT WHILE WEARING THERMACARE [INTENTIONAL DEVICE MISUSE] , USED THE PRODUCT FOR 1 DAY FOR 10 HOURS A DAY [INTENTIONAL DEVICE USE ISSUE] , SCAR [SCAR] , . CASE NARRATIVE:THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER REPORTING FOR HERSELF. A 41-YEAR-OLD FEMALE PATIENT STARTED TO RECEIVE THERMACARE HEATWRAP (THERMACARE LOWER BACK & HIP) (2 COUNT (RED) BOX X LARGE SIZE, DEVICE LOT NUMBER W91247, EXPIRATION DATE MAY2021) FROM (B)(6) 2018 TO (B)(6) 2018 FOR LOWER BACK PAIN. THE PATIENT'S MEDICAL HISTORY INCLUDED BACK PAIN (HAD BEEN TO THE HOSPITAL FOR A CORTISONE SHOT). THE PATIENT WAS NOT PREGNANT AND NOT POST-MENOPAUSAL. THERE WERE NO CONCOMITANT MEDICATIONS. THE PATIENT PREVIOUSLY USED THERMACARE HEATWRAPS 3 PACK FOR OVER A YEAR ((B)(6)) BUT STATED IT DOESNT REALLY HOLD OR STAY ON HER VERY WELL AS SHE IS A BIGGER WOMAN. (UPC, UDI, LOT, OR EXPIRY WAS UNKNOWN). THIS IS WHY SHE DECIDED TO GO UP TO THE 2 PACK WHICH IS THE EXTRA LARGE SIZE. IN THE PAST, SHE HAD BEEN TO THE HOSPITAL FOR A CORTISONE SHOT FOR BACK PAIN. SHE WENT MONTHS WITHOUT USING THE PRODUCT BUT WHEN THE SHOT WORE OFF, SHE HAD RETURNED TO USING JUST THE THERMACARE 2 PACK EXTRA LARGE SIZE. THE PATIENT REPORTED SHE LAST WORE THE PRODUCT WHILE AT WORK. IT WAS PUT ON AROUND 9:00 AM AND REMOVED AROUND 7:00 PM ON (B)(6) 2018. SHE USED THE PRODUCT FOR 1 DAY FOR 10 HOURS. WHEN SHE RETURNED HOME, SHE TOOK IT OFF THEN WENT TO SLEEP. THE BURN WAS NOT NOTICED UNTIL THIS MORNING, (B)(6) 2018, WHEN SHE WENT TO REAPPLY A NEW WRAP. SHE REPORTED THE BURN WAS LOCATED ON HER LOWER BACK. ON THE RIGHT SIDE OF HER LOWER BACK, THE BURN HAD BROKE THE SKIN BUT IT DID NOT ON LEFT SIDE. THE BURN COULD BE SEEN ON BOTH SIDES THOUGH. SHE NOTICED THE SKIN WAS BROKEN BECAUSE SHE RUBBED IT AND IT HURT. THE PATIENT DID NOT CONSULT A HEALTHCARE PROFESSIONAL FOR THE PROBLEMS OR SYMPTOMS. SHE STATED THIS IS NOT A BURN SHE WOULD HAVE TO GO TO HOSPITAL FOR OR SEEK MEDICAL TREATMENT BUT IT DID BREAK THE SKIN. NO HOSPITALIZATION WAS REQUIRED AS A RESULT OF THE BURN. THE BURN WAS LOCATED WHERE THE HEATWRAPS WAS APPLIED. SHE ASKED HER MOTHER IF THERE WAS SOMETHING WRONG WITH HER BACK AND HER MOTHER TOLD HER SHE HAD A BURN. THE PATIENT TREATED THE BURN WITH DISINFECTANT, A&D OINTMENT AND GAUZE TO COVER THE AREA. THE SYMPTOMS LASTED APPROXIMATELY 2 WEEKS AND A SCAR REMAINED FROM AN UNSPECIFIED DATE IN (B)(6) 2018. SHE WAS NOT UNDER THE CARE OF A PHYSICIAN FOR ANY MEDICAL CONDITIONS. THE PATIENT ASSESSED HER SKIN TONE AS MEDIUM (BROWN), NEITHER LIGHT NOR DARK. SHE DENIED HAVING SENSITIVE SKIN AND DOES NOT HAVE ANY ABNORMAL SKIN CONDITIONS. THE PATIENT DENIED USING OTHER HEAT PRODUCTS FOR PAIN RELIEF (ELECTRIC HEATING PAD, HOT WATER BOTTLE, MICROWAVE GEL PACK). THE PATIENT WAS WEARING A TANK TOP AND SHIRT OVER THE PRODUCT AND THE PRODUCT WAS THE ONE THAT SECURES WITH VELCRO, NO ADHESIVE. SHE DID NOT ENGAGE IN EXERCISE WHILE USING THE PRODUCT. SHE DID NOT CHECK HER SKIN UNDER THE PRODUCT WHILE WEARING THERMACARE. SHE DID READ THE USAGE INSTRUCTIONS ON THERMACARE BEFORE USING THE HEATWRAP. THE PATIENT WAS NOT TAKING ANY MEDICATIONS (INCLUDING OVER-THE-COUNTER, HERBAL, NUTRITIONAL OR ANY APPLIED TO THE SKIN) DURING THE TIME THE PROBLEM/SYMPTOM WAS EXPERIENCED. ACTION TAKEN IN RESPONSE TO THE EVENT WAS PERMANENTLY WITHDRAWN ON (B)(6) 2018. THE OUTCOME OF THE EVENT BURN WAS RESOLVED ON AN UNSPECIFIED DATE IN (B)(6) 2018. THE OUTCOME OF THE REMAINING EVENTS WAS UNKNOWN. THE PATIENT REPORTED A SAMPLE OF THE PRODUCT WAS AVAILABLE TO BE RETURNED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE PROVIDED AS IT BECOMES AVAILABLE. FOLLOW-UP (ON (B)(6) 2018): NEW INFORMATION RECEIVED FROM A CONTACTABLE CONSUMER INCLUDES: PATIENT DETAILS, UPDATED ACTION TAKEN WITH SUSPECT PRODUCT, REACTION DATA (ADDITIONAL EVENT SCAR), EVENTS OUTCOME, EVENTS STOP DATE, AND NO HOSPITALIZATION REQUIRED. FOLLOW UP ATTEMPTS ARE COMPLETED. NO FURTHER INFORMATION IS EXPECTED. COMPANY CLINICAL EVALUATION COMMENT BASED ON THE INFORMATION PROVIDED, THE EVENTS BURNS SECOND DEGREE, THERMAL BURN AND INTENTIONAL DEVICE MISUSE AS DESCRIBED ARE CONSIDERED SERIOUS BODILY INJURY REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT DAMAGE OR IMPAIRMENT OF BODY STRUCTURE. THE EVENT INTENTIONAL DEVICE USE ISSUE IS ASSESSED AS NON-SERIOUS. THE EVENTS ARE MEDICALLY ASSESSED AS ASSOCIATED WITH THE USE OF THE DEVICE., COMMENT: BASED ON THE INFORMATION PROVIDED, THE EVENTS BURNS SECOND DEGREE, THERMAL BURN AND INTENTIONAL DEVICE MISUSE AS DESCRIBED ARE CONSIDERED SERIOUS BODILY INJURY REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT DAMAGE OR IMPAIRMENT OF BODY STRUCTURE. THE EVENT INTENTIONAL DEVICE USE ISSUE IS ASSESSED AS NON-SERIOUS. THE EVENTS ARE MEDICALLY ASSESSED AS ASSOCIATED WITH THE USE OF THE DEVICE.
EVENT VERBATIM [PREFERRED TERM] BURN IS LOCATED ON HER LOWER BACK; ON THE RIGHT SIDE IT BROKE THE SKIN/I WAS BURNED ON MY BACK [BURNS SECOND DEGREE] , BURN IS LOCATED ON HER LOWER BACK ON LEFT SIDE/I WAS BURNED ON MY BACK [THERMAL BURN] , SHE DID NOT CHECK HER SKIN UNDER THE PRODUCT WHILE WEARING THERMACARE [INTENTIONAL DEVICE MISUSE] , USED THE PRODUCT FOR 1 DAY FOR 10 HOURS A DAY [INTENTIONAL DEVICE USE ISSUE] , SCAR [SCAR] , . CASE NARRATIVE:THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER REPORTING FOR HERSELF. A 41-YEAR-OLD FEMALE PATIENT STARTED TO RECEIVE THERMACARE HEATWRAP (THERMACARE LOWER BACK & HIP) (2 COUNT (RED) BOX X LARGE SIZE, DEVICE LOT NUMBER W91247, EXPIRATION DATE MAY2021) FROM (B)(6) 2018 TO (B)(6) 2018 FOR LOWER BACK PAIN. THE PATIENT'S MEDICAL HISTORY INCLUDED BACK PAIN (HAD BEEN TO THE HOSPITAL FOR A CORTISONE SHOT). THE PATIENT WAS NOT PREGNANT AND NOT POST-MENOPAUSAL. THERE WERE NO CONCOMITANT MEDICATIONS. THE PATIENT PREVIOUSLY USED THERMACARE HEATWRAPS 3 PACK FOR OVER A YEAR (2017) BUT STATED IT DOESNT REALLY HOLD OR STAY ON HER VERY WELL AS SHE IS A BIGGER WOMAN. (UPC, UDI, LOT, OR EXPIRY WAS UNKNOWN). THIS IS WHY SHE DECIDED TO GO UP TO THE 2 PACK WHICH IS THE EXTRA LARGE SIZE. IN THE PAST, SHE HAD BEEN TO THE HOSPITAL FOR A CORTISONE SHOT FOR BACK PAIN. SHE WENT MONTHS WITHOUT USING THE PRODUCT BUT WHEN THE SHOT WORE OFF, SHE HAD RETURNED TO USING JUST THE THERMACARE 2 PACK EXTRA LARGE SIZE. THE PATIENT REPORTED SHE LAST WORE THE PRODUCT WHILE AT WORK. IT WAS PUT ON AROUND 9:00 AM AND REMOVED AROUND 7:00 PM ON (B)(6) 2018. SHE USED THE PRODUCT FOR 1 DAY FOR 10 HOURS. WHEN SHE RETURNED HOME, SHE TOOK IT OFF THEN WENT TO SLEEP. THE BURN WAS NOT NOTICED UNTIL THIS MORNING, (B)(6) 2018, WHEN SHE WENT TO REAPPLY A NEW WRAP. SHE REPORTED THE BURN WAS LOCATED ON HER LOWER BACK. ON THE RIGHT SIDE OF HER LOWER BACK, THE BURN HAD BROKE THE SKIN BUT IT DID NOT ON LEFT SIDE. THE BURN COULD BE SEEN ON BOTH SIDES THOUGH. SHE NOTICED THE SKIN WAS BROKEN BECAUSE SHE RUBBED IT AND IT HURT. THE PATIENT DID NOT CONSULT A HEALTHCARE PROFESSIONAL FOR THE PROBLEMS OR SYMPTOMS. SHE STATED THIS IS NOT A BURN SHE WOULD HAVE TO GO TO HOSPITAL FOR OR SEEK MEDICAL TREATMENT BUT IT DID BREAK THE SKIN. NO HOSPITALIZATION WAS REQUIRED AS A RESULT OF THE BURN. THE BURN WAS LOCATED WHERE THE HEATWRAPS WAS APPLIED. SHE ASKED HER MOTHER IF THERE WAS SOMETHING WRONG WITH HER BACK AND HER MOTHER TOLD HER SHE HAD A BURN. THE PATIENT TREATED THE BURN WITH DISINFECTANT, A&D OINTMENT AND GAUZE TO COVER THE AREA. THE SYMPTOMS LASTED APPROXIMATELY 2 WEEKS AND A SCAR REMAINED FROM AN UNSPECIFIED DATE IN NOV2018. SHE WAS NOT UNDER THE CARE OF A PHYSICIAN FOR ANY MEDICAL CONDITIONS. THE PATIENT ASSESSED HER SKIN TONE AS MEDIUM (BROWN), NEITHER LIGHT NOR DARK. SHE DENIED HAVING SENSITIVE SKIN AND DOES NOT HAVE ANY ABNORMAL SKIN CONDITIONS. THE PATIENT DENIED USING OTHER HEAT PRODUCTS FOR PAIN RELIEF (ELECTRIC HEATING PAD, HOT WATER BOTTLE, MICROWAVE GEL PACK). THE PATIENT WAS WEARING A TANK TOP AND SHIRT OVER THE PRODUCT AND THE PRODUCT WAS THE ONE THAT SECURES WITH VELCRO, NO ADHESIVE. SHE DID NOT ENGAGE IN EXERCISE WHILE USING THE PRODUCT. SHE DID NOT CHECK HER SKIN UNDER THE PRODUCT WHILE WEARING THERMACARE. SHE DID READ THE USAGE INSTRUCTIONS ON THERMACARE BEFORE USING THE HEATWRAP. THE PATIENT WAS NOT TAKING ANY MEDICATIONS (INCLUDING OVER-THE-COUNTER, HERBAL, NUTRITIONAL OR ANY APPLIED TO THE SKIN) DURING THE TIME THE PROBLEM/SYMPTOM WAS EXPERIENCED. ACTION TAKEN IN RESPONSE TO THE EVENT WAS PERMANENTLY WITHDRAWN ON (B)(6) 2018. THE OUTCOME OF THE EVENTS THERMAL BURN AND BURNS SECOND DEGREE WAS RESOLVED WITH SEQUELAE ON AN UNSPECIFIED DATE IN NOV2018. THE OUTCOME OF THE REMAINING EVENTS WAS UNKNOWN. THE PATIENT REPORTED A SAMPLE OF THE PRODUCT WAS AVAILABLE TO BE RETURNED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE PROVIDED AS IT BECOMES AVAILABLE. FOLLOW-UP (B)(6) 2018): NEW INFORMATION RECEIVED FROM A CONTACTABLE CONSUMER INCLUDES: PATIENT DETAILS, UPDATED ACTION TAKEN WITH SUSPECT PRODUCT, REACTION DATA (ADDITIONAL EVENT SCAR), EVENTS OUTCOME, EVENTS STOP DATE, AND NO HOSPITALIZATION REQUIRED. FOLLOW UP ATTEMPTS ARE COMPLETED. NO FURTHER INFORMATION IS EXPECTED. AMENDMENT: THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO AMEND PREVIOUSLY REPORTED INFORMATION: UPDATED OUTCOME OF EVENTS BURN AND BURN BLISTER FROM NOT RECOVERED TO RECOVERED WITH SEQUELAE. COMPANY CLINICAL EVALUATION COMMENT: BASED ON THE INFORMATION PROVIDED, THE EVENTS BURNS SECOND DEGREE, THERMAL BURN AND INTENTIONAL DEVICE MISUSE AS DESCRIBED ARE CONSIDERED SERIOUS BODILY INJURY REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT DAMAGE OR IMPAIRMENT OF BODY STRUCTURE. THE EVENT INTENTIONAL DEVICE USE ISSUE IS ASSESSED AS NON-SERIOUS. THE EVENTS ARE MEDICALLY ASSESSED AS ASSOCIATED WITH THE USE OF THE DEVICE., COMMENT: BASED ON THE INFORMATION PROVIDED, THE EVENTS BURNS SECOND DEGREE, THERMAL BURN AND INTENTIONAL DEVICE MISUSE AS DESCRIBED ARE CONSIDERED SERIOUS BODILY INJURY REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT DAMAGE OR IMPAIRMENT OF BODY STRUCTURE. THE EVENT INTENTIONAL DEVICE USE ISSUE IS ASSESSED AS NON-SERIOUS. THE EVENTS ARE MEDICALLY ASSESSED AS ASSOCIATED WITH THE USE OF THE DEVICE.
INVESTIGATION SUMMARY: 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 THERE IS "A BURN WHERE THE PRODUCT WAS". THE CAUSE OF THE BURN IS INCONCLUSIVE SINCE REVIEW OF RECORDS DOES NOT PROVIDE EVIDENCE TO SUPPORT DEFECTIVE PRODUCT. THE PRODUCT EFFECT MAY VARY WITH EACH INDIVIDUAL. THE CONSUMER RETURNED SAMPLE HAS NOT BEEN RECEIVED AT THE SITE FOR EVALUATION AS OF 13DEC2018. 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.
EVENT VERBATIM [PREFERRED TERM] BURN IS LOCATED ON HER LOWER BACK; ON THE RIGHT SIDE IT BROKE THE SKIN [BURNS SECOND DEGREE], BURN IS LOCATED ON HER LOWER BACK ON LEFT SIDE [THERMAL BURN], SHE DID NOT CHECK HER SKIN UNDER THE PRODUCT WHILE WEARING THERMACARE [INTENTIONAL DEVICE MISUSE], USED THE PRODUCT FOR 1 DAY FOR 10 HOURS A DAY [INTENTIONAL DEVICE USE ISSUE]. CASE NARRATIVE: THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER REPORTING FOR HERSELF. A (B)(6) YEARS-OLD FEMALE PATIENT STARTED TO RECEIVE THERMACARE HEATWRAP (THERMACARE LOWER BACK & HIP) 2 COUNT (RED) BOX X LARGE SIZE, DEVICE LOT NUMBER W91247, EXPIRATION DATE MAY2021, FROM (B)(6) 2018 TO (B)(6) 2018 FOR BACK PAIN. MEDICAL HISTORY WAS REPORTED AS NONE. THERE WERE NO CONCOMITANT MEDICATIONS. THE PATIENT PREVIOUSLY USED THERMACARE HEATWRAPS 3 PACK FOR OVER A YEAR (2017) BUT STATED IT DOESN'T REALLY HOLD OR STAY ON HER VERY WELL AS SHE IS A BIGGER WOMAN. (UPC, UDI, LOT, OR EXPIRY WAS UNKNOWN). THIS IS WHY SHE DECIDED TO GO UP TO THE 2 PACK WHICH IS THE EXTRA LARGE SIZE. IN THE PAST, SHE HAD BEEN TO THE HOSPITAL FOR A CORTISONE SHOT FOR BACK PAIN. SHE WENT MONTHS WITHOUT USING THE PRODUCT BUT WHEN THE SHOT WORN OFF AND SHE HAD RETURNED TO USING JUST THE THERMACARE 2 PACK EXTRA LARGE SIZE. THE CONSUMER REPORTED SHE LAST WORE THE PRODUCT WHILE AT WORK. IT WAS PUT ON AROUND 09:00 AM AND REMOVED AROUND 07:00 PM ON (B)(6) 2018. SHE USED THE PRODUCT FOR 1 DAY FOR 10 HOURS A DAY, WHEN SHE RETURNED HOME, SHE TOOK IT OFF THEN WENT TO SLEEP. THE BURN WAS NOT NOTICED UNTIL THIS MORNING, (B)(6) 2018, WHEN SHE WENT TO REAPPLY A NEW WRAP, SHE REPORTED BURN IS LOCATED ON HER LOWER BACK; ON THE RIGHT SIDE IT BROKE THE SKIN BUT IT DID NOT ON LEFT SIDE. THE BURN CAN BE SEEN ON BOTH SIDES THOUGH. SHE NOTICED THAT THE SKIN WAS BROKEN BECAUSE SHE RUBBED IT AND IT HURT. CONSUMER DID NOT CONSULT A HEALTHCARE PROFESSIONAL FOR THE PROBLEMS OR SYMPTOMS. CALLER STATED THIS IS NOT A BURN SHE WOULD HAVE TO GO TO HOSPITAL FOR OR SEEK MEDICAL TREATMENT BUT IT DID BREAK THE SKIN. STATED THE A BURN WHERE THE PRODUCT WAS. SHE ASKED HER MOTHER IF THERE WAS SOMETHING WRONG WITH HER BACK AND HER MOTHER TOLD HER SHE HAD A BURN. CONSUMER TREATED IT WITH DISINFECTANT AND A&D OINTMENT, AND GAUZE TO COVER THE AREA. CONSUMER REPORTED SHE IS NOT UNDER THE CARE OF A PHYSICIAN FOR ANY MEDICAL CONDITION. SHE HAS BROWN SKIN, NOT DARK BUT NOT BRIGHT. HER SKIN IS NOT SENSITIVE AND SHE DOES NOT HAVE ANY ABNORMAL SKIN CONDITIONS. CONSUMER DENIED USING OTHER HEAT PRODUCTS FOR PAIN RELIEF (ELECTRIC HEATING PAD, HOT WATER BOTTLE, MICROWAVE GEL PACK). 'SHE WAS WEARING A TANK TOP AND SHIRT AND OVER THE PRODUCT AND THE PRODUCT WAS THE ONE THAT SECURES WITH VELCRO, NO ADHESIVE. 'CONSUMER DID NOT ENGAGE IN EXERCISE WHILE USING THE PRODUCT. SHE DID NOT CHECK HER SKIN UNDER THE PRODUCT WHILE WEARING THERMACARE. SHE DID READ THE USAGE INSTRUCTIONS ON THERMACARE BEFORE YOU USED THE PRODUCT. THE CONSUMER WAS NOT TAKING ANY MEDICATIONS (INCLUDING OVER-THE-COUNTER, HERBAL, NUTRITIONAL OR ANY APPLIED TO THE SKIN) DURING THE TIME, THE PROBLEM/SYMPTOM WAS EXPERIENCED. THE ACTION TAKEN IN RESPONSE TO THE EVENT WAS TEMPORARILY WITHDRAWN. THE OUTCOME OF THE EVENT BURN WAS NOT RECOVERED AND THE OUTCOME OF THE REMAINING EVENTS WERE UNKNOWN. CONSUMER REPORTED A SAMPLE OF THE PRODUCT AVAILABLE TO BE RETURNED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE PROVIDED AS IT BECOMES AVAILABLE. COMPANY CLINICAL EVALUATION COMMENT: BASED ON THE INFORMATION PROVIDED, THE EVENTS BURNS SECOND DEGREE, THERMAL BURN AND INTENTIONAL DEVICE MISUSE AS DESCRIBED ARE CONSIDERED SERIOUS BODILY INJURY REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT DAMAGE OR IMPAIRMENT OF BODY STRUCTURE. THE EVENT INTENTIONAL DEVICE USE ISSUE IS ASSESSED AS NON-SERIOUS. THE EVENTS ARE MEDICALLY ASSESSED AS ASSOCIATED WITH THE USE OF THE DEVICE., COMMENT: BASED ON THE INFORMATION PROVIDED, THE EVENTS BURNS SECOND DEGREE, THERMAL BURN AND INTENTIONAL DEVICE MISUSE AS DESCRIBED ARE CONSIDERED SERIOUS BODILY INJURY REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT DAMAGE OR IMPAIRMENT OF BODY STRUCTURE. THE EVENT INTENTIONAL DEVICE USE ISSUE IS ASSESSED AS NON-SERIOUS. THE EVENTS ARE MEDICALLY ASSESSED AS ASSOCIATED WITH THE USE OF THE DEVICE.
BURN IS LOCATED ON HER LOWER BACK; ON THE RIGHT SIDE IT BROKE THE SKIN/I WAS BURNED ON MY BACK [BURNS SECOND DEGREE], BURN IS LOCATED ON HER LOWER BACK ON LEFT SIDE/I WAS BURNED ON MY BACK [THERMAL BURN], SHE DID NOT CHECK HER SKIN UNDER THE PRODUCT WHILE WEARING THERMACARE [INTENTIONAL DEVICE MISUSE], USED THE PRODUCT FOR 1 DAY FOR 10 HOURS A DAY [INTENTIONAL DEVICE USE ISSUE], SCAR [SCAR]. CASE NARRATIVE: THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER REPORTING FOR HERSELF. A (B)(6)-YEAR-OLD FEMALE PATIENT STARTED TO RECEIVE THERMACARE HEATWRAP (THERMACARE LOWER BACK & HIP) (2 COUNT (RED) BOX X LARGE SIZE, DEVICE LOT NUMBER W91247, EXPIRATION DATE MAY2021) FROM (B)(6) 2018 FOR LOWER BACK PAIN. THE PATIENT'S MEDICAL HISTORY INCLUDED BACK PAIN (HAD BEEN TO THE HOSPITAL FOR A CORTISONE SHOT IN HER BACK). THE PATIENT WAS NOT PREGNANT AND NOT POST-MENOPAUSAL. THERE WERE NO CONCOMITANT MEDICATIONS. THE PATIENT PREVIOUSLY USED THERMACARE HEATWRAPS 3 PACK FOR OVER A YEAR (2017) FOR UNKNOWN INDICATION BUT STATED IT DIDN'T REALLY HOLD OR STAY ON HER VERY WELL AS SHE WAS A BIGGER WOMAN (UPC, UDI, LOT, OR EXPIRY WAS UNKNOWN). THIS WAS WHY SHE DECIDED TO GO UP TO THE 2 PACK WHICH WAS THE EXTRA LARGE SIZE. IN THE PAST, SHE HAD BEEN TO THE HOSPITAL FOR A CORTISONE SHOT FOR BACK PAIN. SHE WENT MONTHS WITHOUT USING THE PRODUCT BUT WHEN THE SHOT WORE OFF, SHE HAD RETURNED TO USING JUST THE THERMACARE 2 PACK EXTRA LARGE SIZE. THE PATIENT REPORTED SHE LAST WORE THE PRODUCT WHILE AT WORK. IT WAS PUT ON AROUND 9:00 AM AND REMOVED AROUND 7:00 PM ON (B)(6) 2018. SHE USED THE PRODUCT FOR 1 DAY FOR 10 HOURS. WHEN SHE RETURNED HOME, SHE TOOK IT OFF THEN WENT TO SLEEP. THE BURN WAS NOT NOTICED UNTIL THIS MORNING, (B)(6) 2018, WHEN SHE WENT TO REAPPLY A NEW WRAP. SHE REPORTED THE BURN WAS LOCATED ON HER LOWER BACK. ON THE RIGHT SIDE OF HER LOWER BACK, THE BURN HAD BROKEN THE SKIN BUT IT DID NOT ON LEFT SIDE. THE BURN COULD BE SEEN ON BOTH SIDES THOUGH. SHE NOTICED THE SKIN WAS BROKEN BECAUSE SHE RUBBED IT AND IT HURT. THE PATIENT DID NOT CONSULT A HEALTHCARE PROFESSIONAL FOR THE PROBLEMS OR SYMPTOMS. SHE STATED THIS WAS NOT A BURN SHE WOULD HAVE TO GO TO HOSPITAL FOR OR SEEK MEDICAL TREATMENT BUT IT DID BREAK THE SKIN. NO HOSPITALIZATION WAS REQUIRED AS A RESULT OF THE BURN. THE BURN WAS LOCATED WHERE THE HEATWRAPS WAS APPLIED. SHE ASKED HER MOTHER IF THERE WAS SOMETHING WRONG WITH HER BACK AND HER MOTHER TOLD HER SHE HAD A BURN. THE PATIENT TREATED THE BURN WITH DISINFECTANT, A&D OINTMENT AND GAUZE TO COVER THE AREA. THE SYMPTOMS LASTED APPROXIMATELY 2 WEEKS AND A SCAR REMAINED FROM AN UNSPECIFIED DATE IN (B)(6) 2018. SHE WAS NOT UNDER THE CARE OF A PHYSICIAN FOR ANY MEDICAL CONDITIONS. THE PATIENT ASSESSED HER SKIN TONE AS MEDIUM (BROWN), NEITHER LIGHT NOR DARK. SHE DENIED HAVING SENSITIVE SKIN AND DID NOT HAVE ANY ABNORMAL SKIN CONDITIONS. THE PATIENT DENIED USING OTHER HEAT PRODUCTS FOR PAIN RELIEF (ELECTRIC HEATING PAD, HOT WATER BOTTLE, MICROWAVE GEL PACK). THE PATIENT WAS WEARING A TANK TOP AND SHIRT OVER THE PRODUCT AND THE PRODUCT WAS THE ONE THAT SECURES WITH VELCRO, NO ADHESIVE. SHE DID NOT ENGAGE IN EXERCISE WHILE USING THE PRODUCT. SHE DID NOT CHECK HER SKIN UNDER THE PRODUCT WHILE WEARING THERMACARE ON (B)(6) 2018. SHE DID READ THE USAGE INSTRUCTIONS ON THERMACARE BEFORE USING THE HEATWRAP. ACTION TAKEN IN RESPONSE TO THE EVENTS WAS PERMANENTLY WITHDRAWN ON (B)(6) 2018. THE OUTCOME OF THE EVENTS "BURN IS LOCATED ON HER LOWER BACK; ON THE RIGHT SIDE IT BROKE THE SKIN" AND "BURN IS LOCATED ON HER LOWER BACK ON LEFT SIDE" WAS RESOLVED WITH SEQUELAE IN (B)(6) 2018. THE OUTCOME OF THE REMAINING EVENTS WAS UNKNOWN. THE PATIENT REPORTED A SAMPLE OF THE PRODUCT WAS AVAILABLE TO BE RETURNED. THE PATIENT REMARKED THE BURN WAS CAUSED BY A MALFUNCTION OF THE DEVICE. AS OF 17DEC2018, ACCORDING TO THE PRODUCT QUALITY COMPLAINT GROUP: 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 THERE IS "A BURN WHERE THE PRODUCT WAS". THE CAUSE OF THE BURN IS INCONCLUSIVE SINCE REVIEW OF RECORDS DOES NOT PROVIDE EVIDENCE TO SUPPORT DEFECTIVE PRODUCT. THE PRODUCT EFFECT MAY VARY WITH EACH INDIVIDUAL. THE CONSUMER RETURNED SAMPLE HAS NOT BEEN RECEIVED AT THE SITE FOR EVALUATION AS OF 13DEC2018. 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. FOLLOW-UP (11DEC2018): NEW INFORMATION RECEIVED FROM A CONTACTABLE CONSUMER INCLUDES: PATIENT DETAILS, UPDATED ACTION TAKEN WITH SUSPECT PRODUCT, REACTION DATA (ADDITIONAL EVENT SCAR), EVENTS OUTCOME, EVENTS STOP DATE, AND NO HOSPITALIZATION REQUIRED. FOLLOW UP ATTEMPTS ARE COMPLETED. NO FURTHER INFORMATION IS EXPECTED. AMENDMENT: THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO AMEND PREVIOUSLY REPORTED INFORMATION: UPDATED OUTCOME OF EVENTS BURN AND BURN BLISTER FROM NOT RECOVERED TO RECOVERED WITH SEQUELAE. FOLLOW-UP (17DEC2018): THIS IS A FOLLOW-UP REPORT FROM THE PRODUCT QUALITY COMPLAINT GROUP INCLUDES INVESTIGATIONAL RESULTS, ONSET DATE OF EVENTS AND EVENT ASSESSMENT. FOLLOW-UP ATTEMPTS ARE COMPLETED. NO FURTHER INFORMATION IS EXPECTED. COMPANY CLINICAL EVALUATION COMMENT: BASED ON THE INFORMATION PROVIDED, THE EVENTS BURNS SECOND DEGREE, THERMAL BURN AND INTENTIONAL DEVICE MISUSE AS DESCRIBED ARE CONSIDERED SERIOUS BODILY INJURY REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT DAMAGE OR IMPAIRMENT OF BODY STRUCTURE. THE EVENT INTENTIONAL DEVICE USE ISSUE AND SCAR ARE ASSESSED AS NON-SERIOUS. THE EVENTS ARE MEDICALLY ASSESSED AS ASSOCIATED WITH THE USE OF THE DEVICE. THE REVIEW OF THE LOT/BATCH RECORDS DOES NOT SUGGEST A DEFECT OR QUALITY ISSUE RELATED TO THE MANUFACTURE OF THIS LOT. NO DEVICE MALFUNCTION HAS BEEN IDENTIFIED. IN THE CASE NARRATIVE THERE IS EVIDENCE OF INTENTIONAL DEVICE MISUSE WHICH MOST LIKELY CONTRIBUTED TO THIS INCIDENT. NO REMEDIAL ACTION/CORRECTIVE ACTION/FIELD SAFETY CORRECTIVE ACTION IS SUGGESTED AT THIS TIME., COMMENT: BASED ON THE INFORMATION PROVIDED, THE EVENTS BURNS SECOND DEGREE, THERMAL BURN AND INTENTIONAL DEVICE MISUSE AS DESCRIBED ARE CONSIDERED SERIOUS BODILY INJURY REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT DAMAGE OR IMPAIRMENT OF BODY STRUCTURE. THE EVENT INTENTIONAL DEVICE USE ISSUE AND SCAR ARE ASSESSED AS NON-SERIOUS. THE EVENTS ARE MEDICALLY ASSESSED AS ASSOCIATED WITH THE USE OF THE DEVICE. THE REVIEW OF THE LOT/BATCH RECORDS DOES NOT SUGGEST A DEFECT OR QUALITY ISSUE RELATED TO THE MANUFACTURE OF THIS LOT. NO DEVICE MALFUNCTION HAS BEEN IDENTIFIED. IN THE CASE NARRATIVE THERE IS EVIDENCE OF INTENTIONAL DEVICE MISUSE WHICH MOST LIKELY CONTRIBUTED TO THIS INCIDENT. NO REMEDIAL ACTION/CORRECTIVE ACTION/FIELD SAFETY CORRECTIVE ACTION IS SUGGESTED AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 923160 | THERMACARE LOWER BACK & HIP | DISPOSABLE PACK, HOT | IMD | PFIZER CONSUMER HEALTH CARE | W91247 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Required Intervention |