THERMACARE HEATWRAP
Report
- Report Number
- 1066015-2017-00131
- Event Type
- Injury
- Date Received
- August 14, 2017
- Report Date
- May 3, 2017
- 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
THIS INVESTIGATION WAS CONDUCTED FOR AN UNKNOWN LOT NUMBER LOWER BACK/HIP (LBH) 8-HOUR PRODUCT. THE ROOT CAUSE CATEGORY IS NON-ASSIGNABLE (COMPLAINT NOT CONFIRMED AS A QUALITY DEFECT). THERE WAS LIMITED DEVICE SPECIFIC INFORMATION PROVIDED, NO BATCH NUMBER OR RETURN SAMPLE WAS AVAILABLE FOR EVALUATION. WITHOUT A BATCH REFERENCE NUMBER 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. LOT TREND ASSMT. & RATIONALE: A LOT TREND WAS NOT PERFORMED AS THE LOT NUMBER IS UNKNOWN. SITE SAMPLE STATUS WAS NOT RECEIVED.
EVENT VERBATIM [PREFERRED TERM] LIKE A BURN /BURN(LESION) [THERMAL BURN] , BURN(LESION) [SKIN LESION] , SHE WAS NOT SUPPOSED TO SLEEP IN IT, BUT SHE DID NOT READ THE INSTRUCTIONS EARLIER. [DEVICE USE ERROR] ,K. CASE NARRATIVE:THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER. A 70-YEAR-OLD FEMALE PATIENT STARTED TO RECEIVE THERMACARE HEATWRAP, VIA AN UNSPECIFIED ROUTE OF ADMINISTRATION FROM AN UNSPECIFIED DATE AT 1 TIME USE FOR BACK PAIN. THE PATIENT MEDICAL HISTORY INCLUDED ONGOING HYPOTHYROIDISM, ONGOING ALLERGIES, ONGOING POTASSIUM DEFICIENCY (TREATED WITH POTASSIUM TO KEEP UP POTASSIUM LEVEL), ONGOING RHEUMATOID ARTHRITIS (RA), ONGOING ARTHRITIS, ONGOING MACULAR D (EYE), ONGOING HIGH BLOOD PRESSURE, ONGOING DRY EYE, ONGOING INCONTINENCE, ONGOING OSTEO-ARTHRITIS, AND ONGOING HIGH CHOLESTEROL. THE PATIENT'S CONCOMITANT MEDICATIONS INCLUDED ONGOING LEVOTHYROXINE AT 0.88 MG, DAILY FOR HYPOTHYROIDISM, ONGOING FOLIC ACID AT 800 UG, 3 TIMES DAILY TO PROTECT LIVER FROM MEDS, MONTELUKAST AT 10 MG, DAILY FOR ALLERGIES, ONGOING POTASSIUM AT 10 MEQ, 3 TIMES DAILY TO KEEP UP POTASSIUM LEVEL, ONGOING PREDNISONE AT 2 MG, DAILY FOR RHEUMATOID ARTHRITIS (RA), ONGOING METHOTREXATE PARENTERALLY AT 1 INJECTION WEEKLY (6CC) FOR ARTHRITIS, ONGOING ASCORBIC ACID, BETACAROTENE, BIOTIN, CALCIUM, CHLORINE, CHROMIUM, COPPER, CYANOCOBALAMIN, DL-ALPHA TOCOPHERYL ACETATE, FOLIC ACID, IODINE, MAGNESIUM, MANGANESE, MOLYBDENUM, NICKEL, NICOTINAMIDE, PANTOTHENIC ACID, PHOSPHORUS, PHYTOMENADIONE, POTASSIUM, PYRIDOXINE HYDROCHLORIDE, RETINOL, RIBOFLAVIN, SELENIUM, SILICON, THIAMINE, VANADIUM, VITAMIN D NOS, XANTOFYL, ZINC (CENTRUM SILVER +50) AT 1 DAILY AS SUPPLEMENT, ONGOING ASCORBIC ACID, CUPRIC OXIDE, TOCOPHERYL ACID SUCCINATE, XANTOFYL, ZEAXANTHIN, ZINC OXIDE (MACULAR) AT 2 CAPSULES DAILY FOR MACULAR D (EYE), ONGOING CALCIUM, CHOLECALCIFEROL (CALCIUM & VITAMIN D) AT 2 CAPSULES, FREQUENCY UNKNOWN FOR BONE HEALTH, ONGOING ALENDRONATE SODIUM AT 70 MG, WEEKLY, (ONCE WEEKLY) FOR BONE HEALTH, ONGOING HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL/HCTZ) 10/12.5, AT 1 TABLET DAILY FOR HIGH BLOOD PRESSURE, ONGOING SALBUTAMOL SULFATE (PROAIR HFA) VIA RESP INHALATION ROUTE AT 2 PUFFS EVERY 4 TO 6 HOURS AS NEEDED, ONGOING BIFIDOBACTERIUM INFANTIS (ALIGN) 1 DAILY, ONGOING SALBUTAMOL SULFATE (ALBUTEROL SULFATE) VIA RESP INHALATION AT 2.5 MG/3ML, AS NEEDED FOR ALLERGIES, ONGOING CARMELLOSE SODIUM, GLYCEROL (OPTIVE SENSITIVE) VIA OPHTHALMIC ROUTE AS NEEDED FOR MACULAR & DRY EYE, ONGOING OXYBUTYNIN AT 15 MG, DAILY FOR INCONTINENCE, ONGOING TOFACITINIB CITRATE (XELJANZ) AT 5 MG, TWICE DAILY FOR RHEUMATOID & OSTEO-ARTHRITIS, AND ONGOING ATORVASTATIN AT 10 MG, ONCE DAILY (IN THE EVENING) FOR HIGH CHOLESTEROL. THE PATIENT REPORTED "I ALSO HAD A PLACE ON MY HIP FROM AN ELECTRODE OR FROM A 'THERMAL CARE PATCH'. THE DR. THOUGHT FIRST THAT I HAD SHINGLES, BUT THEY TREATED THAT ONE PLACE LIKE A BURN. I WAS SLOW HEALING, BUT IS NOW GONE." ON AN UNSPECIFIED DATE. THE PATIENT FURTHER STATED SHE ONLY USED THE HEAT WRAP ONCE. SHE WAS NOT SUPPOSED TO SLEEP IN IT, BUT SHE DID NOT READ THE INSTRUCTIONS EARLIER. SHE HAD THE BURN (LESION) FOR SEVERAL DAYS, BUT NOW THAT IT HAD HEALED. SHE HAD NO CONCERNS. SHE KNEW NOT TO SLEEP WITH IT NOW. THE REPORTER STATED IT WAS NOT SHINGLES. TREATMENT RECEIVED FOR BURN INCLUDED TUBE OF OINTMENT. THE ACTION TAKEN IN RESPONSE TO THE EVENTS FOR THERMACARE HEATWRAP WAS PERMANENTLY DISCONTINUED ON AN UNSPECIFIED DATE. THE OUTCOMES OF EVENTS WERE RESOLVED ON AN UNSPECIFIED DATE. ACCORDING TO THE PRODUCT QUALITY COMPLAINT GROUP: REASONABLY SUGGEST DEVICE MALFUNCTION?: NO. THIS INVESTIGATION WAS CONDUCTED FOR AN UNKNOWN LOT NUMBER LOWER BACK/HIP (LBH) 8-HOUR PRODUCT. THE ROOT CAUSE CATEGORY IS NON-ASSIGNABLE (COMPLAINT NOT CONFIRMED AS A QUALITY DEFECT). THERE WAS LIMITED DEVICE SPECIFIC INFORMATION PROVIDED, NO BATCH NUMBER OR RETURN SAMPLE WAS AVAILABLE FOR EVALUATION. WITHOUT A BATCH REFERENCE NUMBER 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. LOT TREND ASSMT. & RATIONALE: A LOT TREND WAS NOT PERFORMED AS THE LOT NUMBER IS UNKNOWN. SITE SAMPLE STATUS WAS NOT RECEIVED. FOLLOW-UP (01AUG2017): NEW INFORMATION RECEIVED FROM A CONTACTABLE CONSUMER INCLUDED: SUSPECT PRODUCT DATA (DOSE, INDICATION, ACTION TAKEN), MEDICAL HISTORY, CONCOMITANT MEDICATIONS, NEW EVENTS (BURN (LESION), SHE WAS NOT SUPPOSED TO SLEEP IN IT, BUT SHE DID NOT READ THE INSTRUCTIONS EARLIER), AND TREATMENT RECEIVED. AMENDMENT: THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO AMEND PREVIOUSLY REPORTED INFORMATION: THE EVENT SHINGLES WAS DELETED. FOLLOW-UP (18MAR2020): NEW INFORMATION RECEIVED FROM THE PRODUCT QUALITY COMPLAINT GROUP INCLUDED INVESTIGATIONAL RESULTS. FOLLOW-UP ATTEMPTS ARE COMPLETED. NO FURTHER INFORMATION IS EXPECTED., COMMENT: BASED ON THE INFORMATION PROVIDED, THE EVENTS OF "BURN", "SKIN LESION" AND "SHE WAS NOT SUPPOSED TO SLEEP IN IT, BUT SHE DID NOT READ THE INSTRUCTIONS EARLIER" 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. 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 DEVICE USE ERROR 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] LIKE A BURN /BURN(LESION) [THERMAL BURN] , BURN(LESION) [SKIN LESION] , SHE WAS NOT SUPPOSED TO SLEEP IN IT, BUT SHE DID NOT READ THE INSTRUCTIONS EARLIER. [DEVICE USE ERROR] , . CASE NARRATIVE:THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER. A (B)(6) FEMALE PATIENT OF AN UNSPECIFIED ETHNICITY STARTED TO RECEIVE THERMACARE HEATWRAP, VIA AN UNSPECIFIED ROUTE OF ADMINISTRATION FROM AN UNSPECIFIED DATE AT 1 TIME USE FOR BACK PAIN. THE PATIENT MEDICAL HISTORY INCLUDED ONGOING HYPOTHYROIDISM, ALLERGIES, ONGOING POTASSIUM DEFICIENCY, ONGOING ARTHRITIS (RA), ONGOING ARTHRITIS, ONGOING MACULAR D (EYE), ONGOING HIGH BLOOD PRESSURE, ONGOING DRY EYE, ONGOING INCONTINENCE, ONGOING OSTEO-ARTHRITIS, AND ONGOING HIGH CHOLESTEROL. THE PATIENT'S CONCOMITANT MEDICATIONS INCLUDED ONGOING LEVOTHYROXINE AT 0.88 MG, DAILY FOR HYPOTHYROIDISM, ONGOING FOLIC ACID AT 800 UG, 3 TIMES DAILY TO PROTECT LIVER FROM MEDS, MONTELUKAST AT 10 MG, DAILY FOR ALLERGIES, ONGOING POTASSIUM AT 10 MEQ, 3 TIMES DAILY TO KEEP UP POTASSIUM LEVEL, ONGOING PREDNISONE AT 2 MG, DAILY FOR ARTHRITIS (RA), ONGOING METHOTREXATE PARENTERALLY AT 1 INJECTION WEEKLY (6 CC) FOR ARTHRITIS, ONGOING ASCORBIC ACID, BETACAROTENE, BIOTIN, CALCIUM, CHLORINE, CHROMIUM, COPPER, CYANOCOBALAMIN, DL-ALPHA TOCOPHERYL ACETATE, FOLIC ACID, IODINE, MAGNESIUM, MANGANESE, MOLYBDENUM, NICKEL, NICOTINAMIDE, PANTOTHENIC ACID, PHOSPHORUS, PHYTOMENADIONE, POTASSIUM, PYRIDOXINE HYDROCHLORIDE, RETINOL, RIBOFLAVIN, SELENIUM, SILICON, THIAMINE, VANADIUM, VITAMIN D NOS, XANTOFYL, ZINC (CENTRUM SILVER +50) AT 1 DAILY AS SUPPLEMENT, ONGOING ASCORBIC ACID, CUPRIC OXIDE, TOCOPHERYL ACID SUCCINATE, XANTOFYL, ZEAXANTHIN, ZINC OXIDE (MACULAR) AT 2 CAPSULES DAILY FOR MACULAR D (EYE), ONGOING CALCIUM, CHOLECALCIFEROL (CALCIUM AND VITAMIN D) AT 2 CAPSULES, FREQUENCY UNKNOWN FOR BONE HEALTH, ONGOING ALENDRONATE SODIUM AT 70 MG, WEEKLY, (ONCE WEEKLY) FOR BONE HEALTH, ONGOING HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL/HCTZ) 10/12.5, AT 1 TABLET DAILY FOR HIGH BLOOD PRESSURE, ONGOING SALBUTAMOL SULFATE (PROAIR HFA) VIA RESP INHALATION ROUTE AT 2 PUFFS EVERY 4 TO 6 HOURS AS NEEDED, ONGOING BIFIDOBACTERIUM INFANTIS (ALIGN) 1 DAILY, ONGOING SALBUTAMOL SULFATE (ALBUTEROL SULFATE) VIA RESP INHALATION AT 2.5 MG/3 ML, AS NEEDED FOR ALLERGIES, ONGOING CARMELLOSE SODIUM, GLYCEROL (OPTIVE SENSITIVE) VIA OPHTHALMIC ROUTE AS NEEDED FOR MACULAR AND DRY EYE, ONGOING OXYBUTYNIN AT 15 MG, DAILY FOR INCONTINENCE, ONGOING TOFACITINIB CITRATE (XELJANZ) AT 5 MG, TWICE DAILY FOR RHEUMATOID AND OSTEO-ARTHRITIS, AND ONGOING ATORVASTATIN AT 10 MG, ONCE DAILY (IN THE EVENING) FOR HIGH CHOLESTEROL. THE PATIENT REPORTED "I ALSO HAD A PLACE ON MY HIP FROM AN ELECTRODE OR FROM A 'THERMAL CARE PATCH'. THE DR. THOUGHT FIRST THAT I HAD SHINGLES, BUT THEY TREATED THAT ONE PLACE LIKE A BURN. I WAS SLOW HEALING, BUT IS NOW GONE." ON AN UNSPECIFIED DATE. AS OF 01AUG2017, CONSUMER STATED SHE ONLY USED THE HEAT WRAP ONCE. SHE WAS NOT SUPPOSED TO SLEEP IN IT, BUT SHE DID NOT READ THE INSTRUCTIONS EARLIER. SHE HAD THE BURN (LESION) FOR SEVERAL DAYS, BUT NOW THAT IT HAD HEALED. SHE HAD NO CONCERNS. SHE KNEW NOT TO SLEEP WITH IT NOW. THE REPORTER STATED IT WAS NOT SHINGLES. TREATMENT RECEIVED FOR BURN INCLUDED TUBE OF OINTMENT. THE ACTION TAKEN IN RESPONSE TO THE EVENTS FOR THERMACARE HEATWRAP WAS PERMANENTLY DISCONTINUED. THE OUTCOMES OF EVENTS WERE RESOLVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE PROVIDED AS IT BECOMES AVAILABLE. FOLLOW-UP (01AUG2017): NEW INFORMATION RECEIVED FROM A CONTACTABLE CONSUMER INCLUDED: SUSPECT PRODUCT DATA (DOSE, INDICATION, ACTION TAKEN), MEDICAL HISTORY, CONCOMITANT MEDICATIONS, NEW EVENTS (BURN (LESION), SHE WAS NOT SUPPOSED TO SLEEP IN IT, BUT SHE DID NOT READ THE INSTRUCTIONS EARLIER), AND TREATMENT RECEIVED. AMENDMENT: THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO AMEND PREVIOUSLY REPORTED INFORMATION: THE EVENT SHINGLES WAS DELETED. COMPANY CLINICAL EVALUATION COMMENT: BASED ON THE INFORMATION PROVIDED, THE EVENTS OF ""BURN" "SKIN LESION" "SHE WAS NOT SUPPOSED TO SLEEP IN IT, BUT SHE DID NOT READ THE INSTRUCTIONS EARLIER" 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., COMMENT: BASED ON THE INFORMATION PROVIDED, THE EVENTS OF ""BURN" "SKIN LESION" "SHE WAS NOT SUPPOSED TO SLEEP IN IT, BUT SHE DID NOT READ THE INSTRUCTIONS EARLIER" 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 |
|---|---|---|---|---|---|---|---|
| 573282 | THERMACARE HEATWRAP | DISPOSABLE PACK, HOT | IMD | PFIZER CONSUMER HEALTH CARE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Required Intervention | ALBUTEROL SULFATE| ALBUTEROL SULFATE| ALENDRONATE SODIUM| ALENDRONATE SODIUM| ALIGN| ALIGN| ATORVASTATIN| ATORVASTATIN| CALCIUM & VITAMIN D| CALCIUM & VITAMIN D| CENTRUM SILVER +50| CENTRUM SILVER +50| FOLIC ACID| FOLIC ACID| LEVOTHYROXINE| LEVOTHYROXINE| LISINOPRIL/HCTZ| LISINOPRIL/HCTZ| MACULAR| MACULAR| METHOTREXATE| METHOTREXATE| MONTELUKAST| MONTELUKAST| OPTIVE SENSITIVE| OPTIVE SENSITIVE| OPTIVE SENSITIVE| OPTIVE SENSITIVE| OXYBUTYNIN| OXYBUTYNIN| POTASSIUM| POTASSIUM| PREDNISONE| PREDNISONE| PROAIR HFA| PROAIR HFA| XELJANZ| XELJANZ| XELJANZ| XELJANZ| ALBUTEROL SULFATE| ALENDRONATE SODIUM| ALIGN| ATORVASTATIN| CALCIUM & VITAMIN D| CENTRUM SILVER +50| FOLIC ACID| LEVOTHYROXINE| LISINOPRIL/HCTZ| MACULAR| METHOTREXATE| MONTELUKAST| OPTIVE SENSITIVE| OPTIVE SENSITIVE| OXYBUTYNIN| POTASSIUM| PREDNISONE| PROAIR HFA| XELJANZ| XELJANZ |