THERMACARE LOWER BACK & HIP
Report
- Report Number
- 1066015-2019-00202
- Event Type
- Injury
- Date Received
- July 8, 2019
- Date of Event
- February 1, 2019
- Report Date
- May 3, 2019
- Manufacturer
- PFIZER CONSUMER HEALTH CARE
- Product Code
- IMD
- PMA / PMN Number
- K953442
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- 003
Narratives
CONCLUSION: 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 AND/OR RETURN SAMPLE 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. EXPEDITE TREND ASSESSMENT & RATIONALE: AN EVALUATION WAS MADE BY SEARCHING FOR POSSIBLE TRENDS FOR THIS SUBCLASS REQUIRING INVESTIGATION BY THE SITE. THE FOLLOWING COMPLAINT INTAKE, TRIAGE, AND INVESTIGATION (CITI) CUSTOMIZABLE SEARCH WAS PERFORMED: SCOPE: DATE CONTACTED: 03MAY2016 THROUGH 03MAY2019/MANUFACTURING SITE: NAME/COMPLAINT CLASS: EXTERNAL CAUSE INVESTIGATION/COMPLAINT SUB CLASS: ADVERSE EVENT/SERIOUS/UNKNOWN THE CITI CUSTOMIZABLE SEARCH RETURNED A TOTAL OF 2 COMPLAINTS FOR LOWER BACK & HIP (LBH) PRODUCTS DURING THIS TIME PERIOD FOR THE CLASS/SUBCLASS. NONE WERE CONFIRMED TO HAVE A MANUFACTURING PROCESS ROOT CAUSE FOR A COMPLAINT OF ADVERSE EVENT/SERIOUS/UNKNOWN. BASED ON THIS CITI CUSTOMIZABLE SEARCH FOR THE SUBCLASS OF ADVERSE EVENT/SERIOUS/UNKNOWN FOR LBH PRODUCTS THE DATA DID NOT SHOW AN INCREASE OVER TIME (36 MONTHS). THERE IS NOT A TREND IDENTIFIED FOR THE SUBCLASS OF ADVERSE EVENT/SERIOUS/UNKNOWN FOR LBH PRODUCT. EXPEDITED TREND ACTIONS TAKEN: BASED ON THIS CITI CUSTOMIZABLE SEARCH FOR THE SUBCLASS OF ADVERSE EVENT/SERIOUS/UNKNOWN FOR LBH PRODUCTS THE DATA DID NOT SHOW AN INCREASE OVER TIME (36 MONTHS). THERE IS NOT A TREND IDENTIFIED FOR THE SUBCLASS OF ADVERSE EVENT/SERIOUS/UNKNOWN FOR LBH PRODUCT.
EVENT VERBATIM [PREFERRED TERM] BURN AND BLISTER MARKS ON HIS BUTTOCKS/SKIN WAS FALLING OFF [BURNS SECOND DEGREE] , SLEEPING WHILE USING THE PRODUCT / WAS WEARING A SNUG WAISTBAND/BELT OR SIMILAR OR OTHERWISE APPLIED PRESSURE OVER THE AREA/ SKIN WAS NOT CHECKED WHILE USING THE PRODUCT [INTENTIONAL DEVICE MISUSE] , BUT STILL HAS SCARS ON HIS BUTTOCKS [SCAR] , . CASE NARRATIVE:THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER (REPORTING FOR SPOUSE). A 78-YEAR-OLD MALE PATIENT STARTED TO RECEIVE THERMACARE HEATWRAP (THERMACARE LOWER BACK & HIP) DURING (B)(6) 2019 FOR BACK PAIN. MEDICAL HISTORY INCLUDED ONGOING DIABETES, HEART DISEASE, NEUROPATHY IN FEET, ONGOING CONGESTIVE HEART FAILURE, ONGOING COPD, AND ONGOING HIPS HURTING. THE PATIENT WAS USING OTHER UNSPECIFIED CONCOMITANT MEDICATIONS. THE PATIENT EXPERIENCED BURN AND BLISTER MARKS ON HIS BUTTOCKS DURING (B)(6) 2019. THE REPORTER HAD APPLIED THE THERMACARE HEATWRAP TO THE PATIENT WHEN HE WAS GOING TO BED. DURING THE NIGHT HE STATED HIS SKIN WAS FALLING OFF, AND SHE TOLD HIM TO HUSH AND GO TO BED. THE PATIENT'S SKIN WAS NOT CHECKED WHILE USING THE PRODUCT. THE NEXT MORNING WHEN SHE TOOK THE PRODUCT OFF OF HIM, THERE WERE BLISTERS ON HIS BUTTOCKS THAT WERE OPEN/ BUSTED. SHE STATES "HE WAS HURTING SO BAD." SHE CONFIRMED HE WAS SLEEPING WHILE USING THE PRODUCT, AND HAD USED THE PRODUCT FOR ABOUT 5 HOURS ON A SINGLE CONSECUTIVE DAY. THE REPORTER HAD ATTACHED THE PRODUCT ADHESIVE TO HIS BODY, BELOW HIS WAIST ON HIS BUTT CHEEK. HE HAD ON BOXER SHORTS. THE PATIENT HAD WORN SEVERAL LAYERS OF CLOTHING OVER THE THERMACARE PRODUCT AND A SNUG WAISTBAND/BELT OR SIMILAR OR OTHERWISE APPLIED PRESSURE OVER THE AREA. THE REPORTER FURTHER EXPLAINED THAT THE PATIENT HAD USED THE PRODUCT THE NIGHT PRIOR TO GOING TO THE HOSPITAL; HE WAS NOT ADMITTED INTO THE HOSPITAL BECAUSE OF THE BURN, BUT WAS HOSPITALIZED FOR HEART FAILURE, COPD, AND HIS HIPS WERE HURTING. HE WAS ADMITTED AROUND (B)(6) 2019-(B)(6) 2019. THE REPORTER ALSO STATES THE PATIENT WENT INTO THE NURSING HOME. A HEALTHCARE PROFESSIONAL WAS CONSULTED FOR THE PROBLEM; SINCE HE WAS ADMITTED INTO THE HOSPITAL, THE DOCTOR ASKED ABOUT IT. THE HEALTHCARE TEAM KEPT WATCHING THE BURN. WOUND CARE PUT A COUPLE OF "FUNNY" PATCHES/ SPONGY THINGS ON HIS BUTTOCKS AND IT HEALED UP PRETTY GOOD. JUST A BANDAGE WAS USED. THE REPORTER STATES THE BURN LASTED FOR QUITE A WHILE. THE PATIENT HAS RECOVERED COMPLETELY FROM THIS BUT STILL HAS SCARS ON HIS BUTTOCKS. THE PATIENT WAS CURRENTLY UNDER THE CARE OF A PHYSICIAN FOR DIABETES, CONGESTIVE HEART FAILURE, COPD. THE PATIENT'S SKIN TONE WAS CLASSIFIED AS MEDIUM (NEITHER LIGHT NOR DARK). THE PATIENT DID NOT HAVE SENSITIVE SKIN OR ABNORMAL SKIN CONDITIONS. THE BOX PURCHASED FOR THERMACARE LOWER BACK/HIP USED WHILE EXPERIENCING SYMPTOMS WAS A RED BOX. THE REPORTER CONFIRMED READING THE USAGE INSTRUCTIONS ON THERMACARE BEFORE USING THE PRODUCT, AND HAD PREVIOUSLY USED THERMACARE FOR YEARS SINCE IT CAME OUT ON THE MARKET; NO ISSUE WITH PREVIOUS USE. THE PATIENT DID NOT ENGAGE IN EXERCISE WHILE USING THE PRODUCT. THE PACKAGING WAS SEALED AND INTACT. THE PRODUCT WAS NOT AVAILABLE TO BE RETURNED AS IT WAS DISCARDED. CAUSALITY WAS REPORTED AS YES PER THE REPORTER; SHE KNOWS THE BURN WAS CAUSED FROM THE THERMACARE HEATWRAP. THE ACTION TAKEN IN RESPONSE TO THE EVENT WAS PERMANENTLY WITHDRAWN DURING (B)(6) 2019. HE HAS RECOVERED COMPLETELY FROM THIS BUT STILL HAS SCARS ON HIS BUTTOCKS. THE PATIENT RECOVERED FROM BURN / BLISTER AND SKIN FALLING OFF ON AN UNSPECIFIED DATE. THE REPORTER HAD NOT RECOVERED FROM THE SCARS ON HIS BUTTOCKS. THE OUTCOME OF THE REMAINING EVENT WAS UNKNOWN. ACCORDING TO PRODUCT QUALITY COMPLAINT GROUP: CONCLUSION: 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 AND/OR RETURN SAMPLE 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. EXPEDITE TREND ASSESSMENT & RATIONALE: AN EVALUATION WAS MADE BY SEARCHING FOR POSSIBLE TRENDS FOR THIS SUBCLASS REQUIRING INVESTIGATION BY THE SITE. THE FOLLOWING COMPLAINT INTAKE, TRIAGE, AND INVESTIGATION (CITI) CUSTOMIZABLE SEARCH WAS PERFORMED: SCOPE: DATE CONTACTED: 03MAY2016 THROUGH 03MAY2019/MANUFACTURING SITE: NAME/COMPLAINT CLASS: EXTERNAL CAUSE INVESTIGATION/COMPLAINT SUB CLASS: ADVERSE EVENT/SERIOUS/UNKNOWN THE CITI CUSTOMIZABLE SEARCH RETURNED A TOTAL OF 2 COMPLAINTS FOR LOWER BACK & HIP (LBH) PRODUCTS DURING THIS TIME PERIOD FOR THE CLASS/SUBCLASS. NONE WERE CONFIRMED TO HAVE A MANUFACTURING PROCESS ROOT CAUSE FOR A COMPLAINT OF ADVERSE EVENT/SERIOUS/UNKNOWN. BASED ON THIS CITI CUSTOMIZABLE SEARCH FOR THE SUBCLASS OF ADVERSE EVENT/SERIOUS/UNKNOWN FOR LBH PRODUCTS THE DATA DID NOT SHOW AN INCREASE OVER TIME (36 MONTHS). THERE IS NOT A TREND IDENTIFIED FOR THE SUBCLASS OF ADVERSE EVENT/SERIOUS/UNKNOWN FOR LBH PRODUCT. EXPEDITED TREND ACTIONS TAKEN: BASED ON THIS CITI CUSTOMIZABLE SEARCH FOR THE SUBCLASS OF ADVERSE EVENT/SERIOUS/UNKNOWN FOR LBH PRODUCTS THE DATA DID NOT SHOW AN INCREASE OVER TIME (36 MONTHS). THERE IS NOT A TREND IDENTIFIED FOR THE SUBCLASS OF ADVERSE EVENT/SERIOUS/UNKNOWN FOR LBH PRODUCT. FOLLOW UP (01AUG2019): NEW INFORMATION RECEIVED FROM A PRODUCT QUALITY COMPLAINTS GROUP INCLUDED: INVESTIGATION RESULTS. COMPANY CLINICAL EVALUATION COMMENT: BASED ON THE INFORMATION PROVIDED, THE EVENTS OF "SLEEPING WHILE USING THE PRODUCT" AND "BURN BLISTER" AS DESCRIBED ARE CONSIDERED SERIOUS BODILY INJURY REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT DAMAGE OR IMPAIRMENT OF BODY STRUCTURE. THE EVENT SCAR IS ASSESSED AS NON-SERIOUS. THE EVENTS ARE MEDICALLY ASSESSED AS ASSOCIATED WITH THE USE OF THE DEVICE. THERE WAS LIMITED DEVICE SPECIFIC INFORMATION PROVIDED, NO BATCH NUMBER OR RETURN SAMPLE WAS AVAILABLE FOR EVALUATION. WITHOUT A BATCH REFERENCE NUMBER AND/OR RETURN SAMPLE A MANUFACTURING AND TECHNICAL EVALUATION CANNOT BE COMPLETED FOR THE WRAP INVOLVED IN THIS CASE. PRODUCT EFFECT VARIES WITH EACH INDIVIDUAL. 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 OF "SLEEPING WHILE USING THE PRODUCT" AND "BURN BLISTER" AS DESCRIBED ARE CONSIDERED SERIOUS BODILY INJURY REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT DAMAGE OR IMPAIRMENT OF BODY STRUCTURE. THE EVENT SCAR IS ASSESSED AS NON-SERIOUS. THE EVENTS ARE MEDICALLY ASSESSED AS ASSOCIATED WITH THE USE OF THE DEVICE. THERE WAS LIMITED DEVICE SPECIFIC INFORMATION PROVIDED, NO BATCH NUMBER OR RETURN SAMPLE WAS AVAILABLE FOR EVALUATION. WITHOUT A BATCH REFERENCE NUMBER AND/OR RETURN SAMPLE A MANUFACTURING AND TECHNICAL EVALUATION CANNOT BE COMPLETED FOR THE WRAP INVOLVED IN THIS CASE. PRODUCT EFFECT VARIES WITH EACH INDIVIDUAL. 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 VERBATIM [PREFERRED TERM] BURN AND BLISTER MARKS ON HIS BUTTOCKS/SKIN WAS FALLING OFF [BURNS SECOND DEGREE], SLEEPING WHILE USING THE PRODUCT / WAS WEARING A SNUG WAISTBAND/BELT OR SIMILAR OR OTHERWISE APPLIED PRESSURE OVER THE AREA [INTENTIONAL DEVICE MISUSE] , BUT STILL HAS SCARS ON HIS BUTTOCKS [SCAR]. CASE NARRATIVE: THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER (REPORTING FOR SPOUSE). A (B)(6) YEAR-OLD MALE PATIENT STARTED TO RECEIVE THERMACARE HEATWRAP (THERMACARE LOWER BACK & HIP) DURING (B)(6) 2019 FOR BACK PAIN. MEDICAL HISTORY INCLUDED ONGOING DIABETES, HEART DISEASE, NEUROPATHY IN FEET, ONGOING HEART FAILURE, ONGOING COPD, AND ONGOING HIPS HURTING. THE PATIENT WAS USING OTHER UNSPECIFIED CONCOMITANT MEDICATIONS. THE PATIENT EXPERIENCED BURN AND BLISTER MARKS ON HIS BUTTOCKS DURING (B)(6) 2019. THE REPORTER HAD APPLIED THE THERMACARE HEATWRAP TO THE PATIENT WHEN HE WAS GOING TO BED. DURING THE NIGHT HE STATED HIS SKIN WAS FALLING OFF, AND SHE TOLD HIM TO HUSH AND GO TO BED. THE PATIENT'S SKIN WAS NOT CHECKED WHILE USING THE PRODUCT. THE NEXT MORNING WHEN SHE TOOK THE PRODUCT OFF OF HIM, THERE WERE BLISTERS ON HIS BUTTOCKS THAT WERE OPEN/ BUSTED. SHE STATES "HE WAS HURTING SO BAD." SHE CONFIRMED HE WAS SLEEPING WHILE USING THE PRODUCT, AND HAD USED THE PRODUCT FOR ABOUT 5 HOURS ON A SINGLE CONSECUTIVE DAY. THE REPORTER HAD ATTACHED THE PRODUCT ADHESIVE TO HIS BODY, BELOW HIS WAIST ON HIS BUTT CHEEK. HE HAD ON BOXER SHORTS. THE PATIENT HAD WORN SEVERAL LAYERS OF CLOTHING OVER THE THERMACARE PRODUCT AND A SNUG WAISTBAND/BELT OR SIMILAR OR OTHERWISE APPLIED PRESSURE OVER THE AREA. THE REPORTER FURTHER EXPLAINED THAT THE PATIENT HAD USED THE PRODUCT THE NIGHT PRIOR TO GOING TO THE HOSPITAL; HE WAS NOT ADMITTED INTO THE HOSPITAL BECAUSE OF THE BURN, BUT WAS HOSPITALIZED FOR HEART FAILURE, COPD, AND HIS HIPS WERE HURTING. HE WAS ADMITTED AROUND (B)(6) 2019. THE REPORTER ALSO STATES THE PATIENT WENT INTO THE NURSING HOME. A HEALTHCARE PROFESSIONAL WAS NOT CONSULTED FOR THE PROBLEM; HOWEVER, SINCE HE WAS ADMITTED INTO THE HOSPITAL, THE DOCTOR ASKED ABOUT IT. THE HEALTHCARE TEAM KEPT WATCHING THE BURN. WOUND CARE PUT A COUPLE OF "FUNNY" PATCHES/ SPONGY THINGS ON HIS BUTTOCKS AND IT HEALED UP PRETTY GOOD. JUST A BANDAGE WAS USED. THE REPORTER STATES THE BURN LASTED FOR QUITE A WHILE. THE PATIENT HAS RECOVERED COMPLETELY FROM THIS BUT STILL HAS SCARS ON HIS BUTTOCKS. THE PATIENT WAS CURRENTLY UNDER THE CARE OF A PHYSICIAN FOR DIABETES, CONGESTIVE HEART FAILURE, COPD. THE PATIENT'S SKIN TONE WAS CLASSIFIED AS LIGHT. THE PATIENT DID NOT HAVE SENSITIVE SKIN OR ABNORMAL SKIN CONDITIONS. THE BOX PURCHASED FOR THERMACARE LOWER BACK/HIP USED WHILE EXPERIENCING SYMPTOMS WAS A RED BOX. THE REPORTER CONFIRMED READING THE USAGE INSTRUCTIONS ON THERMACARE BEFORE USING THE PRODUCT, AND HAD PREVIOUSLY USED THERMACARE FOR YEARS SINCE IT CAME OUT ON THE MARKET; NO ISSUE WITH PREVIOUS USE. THE PATIENT DID NOT ENGAGE IN EXERCISE WHILE USING THE PRODUCT. THE PACKAGING WAS SEALED AND INTACT. THE PRODUCT WAS NOT AVAILABLE TO BE RETURNED AS IT WAS DISCARDED. CAUSALITY WAS REPORTED AS YES PER THE REPORTER; SHE KNOWS THE BURN WAS CAUSED FROM THE THERMACARE HEATWRAP. THE ACTION TAKEN IN RESPONSE TO THE EVENT WAS PERMANENTLY WITHDRAWN DURING (B)(6) 2019. HE HAS RECOVERED COMPLETELY FROM THIS BUT STILL HAS SCARS ON HIS BUTTOCKS. THE PATIENT RECOVERED FROM BURN / BLISTER AND SKIN FALLING OFF ON AN UNSPECIFIED DATE. THE REPORTER HAD NOT RECOVERED FROM THE SCARS ON HIS BUTTOCKS. THE OUTCOME OF THE REMAINING EVENT 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 EVENTS OF "SLEEPING WHILE USING THE PRODUCT" AND "BURN BLISTER" AS DESCRIBED ARE CONSIDERED SERIOUS BODILY INJURY POTENTIALLY REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT DAMAGE OR IMPAIRMENT OF BODY STRUCTURE. THE EVENT SCAR 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 OF "SLEEPING WHILE USING THE PRODUCT" AND "BURN BLISTER" AS DESCRIBED ARE CONSIDERED SERIOUS BODILY INJURY POTENTIALLY REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT DAMAGE OR IMPAIRMENT OF BODY STRUCTURE. THE EVENT SCAR IS ASSESSED AS NON-SERIOUS. THE EVENTS ARE MEDICALLY ASSESSED AS ASSOCIATED WITH THE USE OF THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 560826 | THERMACARE LOWER BACK & HIP | DISPOSABLE PACK, HOT | IMD | PFIZER CONSUMER HEALTH CARE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Required Intervention |