THERMACARE LOWER BACK & HIP
Report
- Report Number
- 1066015-2017-00117
- Event Type
- Injury
- Date Received
- July 10, 2017
- Date of Event
- March 31, 2017
- Report Date
- April 26, 2017
- Manufacturer
- PFIZER CONSUMER HEALTH CARE
- Product Code
- IMD
- PMA / PMN Number
- K953442
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
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 WRAP/PATCH/PAD TOO HOT. 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.
EVENT VERBATIM [PREFERRED TERM] 2ND DEGREE BURN IN THE LOWER BACK AND WAS BETWEEN 5 AND 10 CM OF LENGTH, HAD A 2MM WOUND AND MARKS (SCABBY ASPECT) [BURNS SECOND DEGREE] , ATTACHED THE HEATWRAP DIRECTLY TO THE BODY AND HAD READ THE USAGE INSTRUCTIONS PRIOR TO USE [INTENTIONAL DEVICE MISUSE]. CASE NARRATIVE:THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE PHARMACIST AND PHYSICIAN. A 79-YEAR-OLD MALE PATIENT STARTED TO USE THERMACARE HEATWRAPS (THERMACARE LOWER BACK AND HIP) (DEVICE LOT #: 5190012, EXPIRATION DATE: NOV2020) (LOT NUMBER INVALID) FOR 6 HOURS FOR LUMBAR PAIN ON 31MAR2017. THE PATIENT'S MEDICAL HISTORY INCLUDED CARDIAC DISORDER, CARDIAC ARRHYTHMIA BY ATRIAL FIBRILLATION SINCE 2006 AND ONGOING, SENSITIVE SKIN FROM AN UNKNOWN DATE AND UNKNOWN IF ONGOING, ARTERIAL HYPERTENSION FROM AN UNKNOWN DATE AND UNKNOWN IF ONGOING, ONGOING DIABETES, BLOCKED NOSE FROM AN UNKNOWN DATE AND UNKNOWN IF ONGOING, PULMONARY INFECTION FROM AN UNKNOWN DATE AND UNKNOWN IF ONGOING, THROMBOCYTOPENIA FROM AN UNKNOWN DATE. CONCOMITANT MEDICATIONS INCLUDED ALLOPURINOL; METFORMIN EMBONATE (STAGID); RIVAROXABAN (XARELTO) FOR CARDIOLOGY DISORDERS; CANDESARTAN CILEXETIL, HYDROCHLOROTHIAZIDE (CANDESARTAN+HYDROCHLOROTHIAZIDE) FOR ARTERIAL HYPERTENSION; ACEBUTOLOL FOR CARDIAC DISORDERS AND MANIDIPINE HYDROCHLORIDE (IPERTEN) FOR ARTERIAL HYPERTENSION. THE PATIENT RECEIVED FROM (B)(6) 2017 TO (B)(6) 2017 THE FOLLOWING TREATMENT FOR BLOCKED NOSE AND PULMONARY INFECTION: AMOXICILLINE TABLETS, TAKEN VIA ORAL ROUTE, TIXOCORTOL PIVALATE (PIVALONE), NASAL SPRAY, VIA NASAL ROUTE, AND AMBROXOL, ORAL SOLUTION, TAKEN VIA ORAL ROUTE FOR BLOCKED NOSE AND PULMONARY INFECTION. HE PREVIOUSLY USED OTHER HEAT PRODUCTS FOR PAIN RELIEF SUCH AS HEATING BAG WITH SEEDS IN (B)(6) 2016 FOR PERIODS OF 30 MINUTES AND THE PATIENT HAD NOT PREVIOUSLY EXPERIENCED A PROBLEM/SYMPTOM WITH ANY OF THESE PRODUCTS. ON (B)(6) 2017, THE PATIENT USED THE HEATWRAP FOR THE FIRST TIME AND EXPERIENCED A SECOND DEGREE BURN AT 6 PM. THE SECOND DEGREE BURN OCCURRED IN THE LOWER BACK AND WAS BETWEEN 5 AND 10 CM OF LENGTH. THE PATIENT CONSULTED A HEALTHCARE PROFESSIONAL (GENERAL PRACTITIONER) AS A RESULT OF THE BURN. IT WAS REPORTED HE WAS WEARING SEVERAL LAYERS OF CLOTHING OVER THE HEATWRAP AND ATTACHED THE HEATWRAP DIRECTLY TO THE BODY. SURGICAL INTERVENTION WAS NOT REQUIRED. ACCORDING TO THE PHYSICIAN, THE PATIENT WOULD NOT EXPERIENCE LONG-TERM SEQUELA SUCH AS SCARRING. THE EVENT WAS CONSIDERED AS NON-SERIOUS ACCORDING TO THE PHYSICIAN. THE PATIENT STILL HAD A 2MM WOUND AND MARKS (SCABBY ASPECT). THE PHARMACIST REPORTED THE PATCH WAS APPLIED DIRECTLY TO THE PATIENT'S SKIN, WHICH WAS A MISUSE CONSIDERING THE PATIENT'S AGE. THE PATIENT'S SKIN WAS ASSESSED AS VERY LIGHT TO FAIR. HE DID NOT ENGAGE IN EXERCISE WHILE USING THE HEATWRAP. THE PATIENT HAD READ THE USAGE INSTRUCTIONS PRIOR TO DEVICE USAGE. ACTION TAKEN WITH THE SUSPECT PRODUCT WAS PERMANENTLY WITHDRAWN ON (B)(6) 2017. THERAPEUTIC MEASURES TAKEN FOR BOTH EVENTS INCLUDED DRESSINGS FOR ONE MONTH AND A HALF (NURSE CARES WITH PARAFFIN TULLE, EOSINE AND PADS), VASELLINE POMADE APPLICATION FOR SEVERAL DAYS. CLINICAL OUTCOME OF THE EVENT SECOND DEGREE BURN WAS RESOLVED (B)(6) 2017 AND THE OUTCOME OF THE REMAINING EVENT WAS UNKNOWN. THE PHARMACIST DID NOT SUSPECT A CAUSAL RELATIONSHIP BETWEEN THERMACARE AND THE OCCURRENCE OF THE EVENT. THE PHYSICIAN CONSIDERED THE EVENT OF SECOND DEGREE BURNS AS RELATED TO THERMACARE HEATWRAPS. ACCORDING TO THE PRODUCT QUALITY COMPLAINT GROUP ON 18MAR2020: 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 WRAP/PATCH/PAD TOO HOT. 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 FOLLOW-UP (27JUN2017): NEW INFORMATION RECEIVED FROM THE CONTACTABLE PHARMACIST INCLUDES: UPDATED PATIENT AGE AND GENDER, PATIENT MEDICAL HISTORY, UPDATED SUSPECT PRODUCT, SUSPECT PRODUCT INDICATION, SUSPECT PRODUCT LOT NUMBER AND EXPIRATION DATE, SUSPECT PRODUCT START DATE, CONCOMITANT MEDICATION, REACTION DATA (UPDATED EVENT THERMAL BURN TO BURNS SECOND DEGREE AND ADDED EVENT INTENTIONAL DEVICE MISUSE), EVENT ONSET DATE, THERAPEUTIC MEASURES TAKEN AND EVENT OUTCOME. THIS CASE HAS BEEN UPGRADED TO A SERIOUS REPORTABLE MEDICAL DEVICE REPORT. AMENDMENT: THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO AMEND PREVIOUSLY REPORTED INFORMATION: UPDATED CONCOMITANT MEDICATION AMOXICILLIN START/STOP DATES AND UPDATED DESCRIPTION TO BE CODED FIELD FROM '2ND DEGREE BURN' TO 'SECOND DEGREE BURNS'. FOLLOW-UP (11AUG2017): NEW INFORMATION RECEIVED FROM A CONTACTABLE PHYSICIAN INCLUDED MEDICAL HISTORY, PRODUCT DATA (UPDATED START/STOP DATES, ACTION TAKEN), REACTION DATA (UPDATED ONSET DATE, EVENT VERBATIM DESCRIPTION, TREATMENT, OUTCOME, SERIOUSNESS AND CAUSALITY ASSESSMENT). FOLLOW-UP (05JUL2017): THIS FOLLOW-UP IS BEING SUBMITTED TO NOTIFY THAT AN INVESTIGATION OF THE DEVICE CANNOT BE CONDUCTED. THE LOCAL PRODUCT QUALITY GROUP CONFIRMED THE LOT NUMBER WAS INVALID AND IT WAS NOT POSSIBLE TO RETRIEVE IT AS THE SAMPLE HAS BEEN DISCARDED. UPDATED REACTION DATA (SUBSUMED EVENT WOUND UNDER EVENT SECOND DEGREE BURN. FOLLOW-UP ATTEMPTS HAVE BEEN COMPLETED AND NO FURTHER INFORMATION IS EXPECTED. FOLLOW-UP (06OCT2017): NEW INFORMATION WAS PROVIDED BY THE CONTACTABLE PHARMACIST WHO CONFIRMED THERMACARE HEATWRAP WAS DIRECTLY APPLIED ON THE PATIENT'S SKIN (WHICH WAS A MISUSE CONSIDERING THE PATIENT'S AGE). FOLLOW-UP (18MAR2020): NEW INFORMATION RECEIVED FROM PRODUCT QUALITY COMPLAINT GROUP INCLUDES INVESTIGATION RESULTS., COMMENT: BASED ON THE INFORMATION PROVIDED, THE EVENTS OF "SECOND DEGREE BURN" AND "INTENTIONAL DEVICE MISUSE" ARE CONSIDERED SERIOUS BODILY INJURY 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 "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] 2ND DEGREE BURN [BURNS SECOND DEGREE] , WEARING SEVERAL LAYERS OF CLOTHING OVER THE HEATWRAP; PHARMACIST REPORTED THE PATCH WAS NOT APPLIED ON SKIN AND THIS WAS A MISUSE [INTENTIONAL DEVICE MISUSE] , STILL HAD A 2MM WOUND AND MARKS (SCABBY ASPECT) [WOUND] , STILL HAD A 2MM WOUND AND MARKS (SCABBY ASPECT) [SCAR] , . CASE NARRATIVE:THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE PHARMACIST. A (B)(6) MALE PATIENT STARTED TO USE THERMACARE HEATWRAPS (THERMACARE LOWER BACK AND HIP) (DEVICE LOT #: 5190012, EXPIRATION DATE: NOV2020) ON (B)(6) 2017 FOR 6 HOURS FOR LUMBAR PAIN. THE PATIENT'S MEDICAL HISTORY INCLUDED AN UNSPECIFIED CARDIAC DISORDER FROM AN UNKNOWN DATE AND UNKNOWN IF ONGOING, SENSITIVE SKIN FROM AN UNKNOWN DATE AND UNKNOWN IF ONGOING, ARTERIAL HYPERTENSION FROM AN UNKNOWN DATE AND UNKNOWN IF ONGOING, DIABETES FROM AN UNKNOWN DATE AND UNKNOWN IF ONGOING, BLOCKED NOSE FROM AN UNKNOWN DATE AND UNKNOWN IF ONGOING AND PULMONARY INFECTION FROM AN UNKNOWN DATE AND UNKNOWN IF ONGOING. CONCOMITANT MEDICATIONS INCLUDED ALLOPURINOL (TRADE NAME NOT SPECIFIED) 200, AT 1 INTAKE DAILY, METFORMIN EMBONATE (STAGID) 700, 3 INTAKES DAILY, RIVAROXABAN (XARELTO) 20, AT ONE INTAKE DAILY FOR CARDIAC DISORDERS, CANDESARTAN/HYDROCHLOROTHIAZIDE (TRADE NAME NOT SPECIFIED) 16, AT 1 INTAKE DAILY FOR ARTERIAL HYPERTENSION, ACEBUTOLOL (TRADE NAME NOT SPECIFIED) 200, AT 1 INTAKE DAILY FOR CARDIAC DISORDERS AND MANIDIPINE HYDROCHLORIDE (IPERTEN) 10, AT 1 INTAKE DAILY FOR ARTERIAL HYPERTENSION. THE PATIENT RECEIVED (B)(6) 2017 THE FOLLOWING TREATMENT FOR BLOCKED NOSE AND PULMONARY INFECTION: VASELINE POMADE AND URGOPORE PADS VIA CUTANEOUS ROUTE, AMOXICILLINE (TRADE NAME NOT SPECIFIED), TABLETS, TAKEN VIA ORAL ROUTE AT 1G THRICE DAILY, TIXOCORTOL PIVALATE (PIVALONE), NASAL SPRAY, VIA NASAL ROUTE, 2 TO 4 TIMES DAILY AND AMBROXOL (TRADE NAME NOT SPECIFIED), ORAL SOLUTION, TAKEN VIA ORAL ROUTE 5 TO 10ML, TWICE DAILY. ON (B)(6) 2017 (EVENT DATE ALSO REPORTED AS (B)(6) 2017), THE PATIENT USED THE HEATWRAP FOR THE FIRST TIME AND EXPERIENCED A SECOND DEGREE BURN AT 6 PM. THE PATIENT CONSULTED A HEALTHCARE PROFESSIONAL (GENERAL PRACTITIONER) AS A RESULT OF THE BURN. IT WAS REPORTED HE WAS WEARING SEVERAL LAYERS OF CLOTHING OVER THE HEATWRAP AND ATTACHED THE ADHESIVE TO THE BODY. AS OF (B)(6) 2017, THE SYMPTOMS WERE REPORTED AS NOT RESOLVED. THE PATIENT STILL HAD A 2MM WOUND AND MARKS (SCABBY ASPECT). THE PHARMACIST REPORTED THE PATCH WAS NOT APPLIED ON SKIN AND THIS WAS A MISUSE. THE PATIENT'S SKIN WAS ASSESSED AS VERY LIGHT TO FAIR. HE DID NOT ENGAGE IN EXERCISE WHILE USING THE HEATWRAP. THE PATIENT HAD READ THE USAGE INSTRUCTIONS PRIOR TO DEVICE USAGE. HE PREVIOUSLY USED OTHER HEAT PRODUCTS FOR PAIN RELIEF SUCH AS HEATING BAG WITH SEEDS IN (B)(6) 2016 FOR PERIODS OF 30 MINUTES AND THE PATIENT HAD NOT PREVIOUSLY EXPERIENCED A PROBLEM/SYMPTOM WITH ANY OF THESE PRODUCTS. ACTION TAKEN WITH THE SUSPECT PRODUCT WAS UNKNOWN. THERAPEUTIC MEASURES TAKEN INCLUDED DRESSINGS FOR ONE MONTH AND A HALF (NURSE CARES WITH PARAFFIN TULLE, EOSINE AND PADS). CLINICAL OUTCOME OF THE EVENTS WAS NOT RESOLVED. THE PHARMACIST DID NOT SUSPECT A CAUSAL RELATIONSHIP BETWEEN THERMACARE AND THE OCCURRENCE OF THE EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE PROVIDED AS IT BECOMES AVAILABLE. FOLLOW-UP ((B)(6) 2017) : NEW INFORMATION RECEIVED FROM THE CONTACTABLE PHARMACIST INCLUDES: UPDATED PATIENT AGE AND GENDER, PATIENT MEDICAL HISTORY, UPDATED SUSPECT PRODUCT, SUSPECT PRODUCT INDICATION, SUSPECT PRODUCT LOT NUMBER AND EXPIRATION DATE, SUSPECT PRODUCT START DATE, CONCOMITANT MEDICATION, REACTION DATA (UPDATED EVENT THERMAL BURN TO BURNS SECOND DEGREE AND ADDED EVENT INTENTIONAL DEVICE MISUSE), EVENT ONSET DATE, THERAPEUTIC MEASURES TAKEN AND EVENT OUTCOME. THIS CASE HAS BEEN UPGRADED TO A SERIOUS REPORTABLE MEDICAL DEVICE REPORT. COMPANY CLINICAL EVALUATION COMMENT: BASED ON THE INFORMATION PROVIDED, THE EVENTS OF "SECOND DEGREE BURN" "PHARMACIST REPORTED THE PATCH WAS NOT APPLIED ON SKIN AND THIS WAS A MISUSE" AS DESCRIBED ARE CONSIDERED SERIOUS BODILY INJURY POTENTIALLY REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT DAMAGE OR IMPAIRMENT OF BODY STRUCTURE. THE EVENTS OF STILL HAD A 2MM WOUND AND MARKS (SCABBY ASPECT)" ARE NON-SERIOUS. THE EVENTS ARE MEDICALLY ASSESSED AS ASSOCIATED WITH THE USE OF THE DEVICE., COMMENT: BASED ON THE INFORMATION PROVIDED, THE EVENTS OF "SECOND DEGREE BURN" "PHARMACIST REPORTED THE PATCH WAS NOT APPLIED ON SKIN AND THIS WAS A MISUSE" AS DESCRIBED ARE CONSIDERED SERIOUS BODILY INJURY POTENTIALLY REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT DAMAGE OR IMPAIRMENT OF BODY STRUCTURE. THE EVENTS OF STILL HAD A 2MM WOUND AND MARKS (SCABBY ASPECT)" ARE NON-SERIOUS. THE EVENTS ARE MEDICALLY ASSESSED AS ASSOCIATED WITH THE USE OF THE DEVICE.
EVENT VERBATIM [PREFERRED TERM] 2ND DEGREE BURN [BURNS SECOND DEGREE] , WEARING SEVERAL LAYERS OF CLOTHING OVER THE HEATWRAP; PHARMACIST REPORTED THE PATCH WAS NOT APPLIED ON SKIN AND THIS WAS A MISUSE [INTENTIONAL DEVICE MISUSE] , STILL HAD A 2MM WOUND AND MARKS (SCABBY ASPECT) [WOUND] , STILL HAD A 2MM WOUND AND MARKS (SCABBY ASPECT) [SCAR] , . CASE NARRATIVE:THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE PHARMACIST. A (B)(6) PATIENT STARTED TO USE THERMACARE HEATWRAPS (THERMACARE LOWER BACK AND HIP) (DEVICE LOT #: 5190012, EXPIRATION DATE: NOV2020) ON (B)(6) 2017 FOR 6 HOURS FOR LUMBAR PAIN. THE PATIENT'S MEDICAL HISTORY INCLUDED AN UNSPECIFIED CARDIAC DISORDER FROM AN UNKNOWN DATE AND UNKNOWN IF ONGOING, SENSITIVE SKIN FROM AN UNKNOWN DATE AND UNKNOWN IF ONGOING, ARTERIAL HYPERTENSION FROM AN UNKNOWN DATE AND UNKNOWN IF ONGOING, DIABETES FROM AN UNKNOWN DATE AND UNKNOWN IF ONGOING, BLOCKED NOSE FROM AN UNKNOWN DATE AND UNKNOWN IF ONGOING AND PULMONARY INFECTION FROM AN UNKNOWN DATE AND UNKNOWN IF ONGOING. CONCOMITANT MEDICATIONS INCLUDED ALLOPURINOL (TRADE NAME NOT SPECIFIED) 200, AT 1 INTAKE DAILY, METFORMIN EMBONATE (STAGID) 700, 3 INTAKES DAILY, RIVAROXABAN (XARELTO) 20, AT ONE INTAKE DAILY FOR CARDIAC DISORDERS, CANDESARTAN/HYDROCHLOROTHIAZIDE (TRADE NAME NOT SPECIFIED) 16, AT 1 INTAKE DAILY FOR ARTERIAL HYPERTENSION, ACEBUTOLOL (TRADE NAME NOT SPECIFIED) 200, AT 1 INTAKE DAILY FOR CARDIAC DISORDERS AND MANIDIPINE HYDROCHLORIDE (IPERTEN) 10, AT 1 INTAKE DAILY FOR ARTERIAL HYPERTENSION. THE PATIENT RECEIVED FROM (B)(6) 2017 TO (B)(6) 2017 THE FOLLOWING TREATMENT FOR BLOCKED NOSE AND PULMONARY INFECTION: VASELINE POMADE AND URGOPORE PADS VIA CUTANEOUS ROUTE, AMOXICILLINE (TRADE NAME NOT SPECIFIED), TABLETS, TAKEN VIA ORAL ROUTE AT 1G THRICE DAILY, TIXOCORTOL PIVALATE (PIVALONE), NASAL SPRAY, VIA NASAL ROUTE, 2 TO 4 TIMES DAILY AND AMBROXOL (TRADE NAME NOT SPECIFIED), ORAL SOLUTION, TAKEN VIA ORAL ROUTE 5 TO 10ML, TWICE DAILY. ON (B)(6) 2017 (EVENT DATE ALSO REPORTED AS (B)(6) 2017), THE PATIENT USED THE HEATWRAP FOR THE FIRST TIME AND EXPERIENCED A SECOND DEGREE BURN AT 6 PM. THE PATIENT CONSULTED A HEALTHCARE PROFESSIONAL (GENERAL PRACTITIONER) AS A RESULT OF THE BURN. IT WAS REPORTED HE WAS WEARING SEVERAL LAYERS OF CLOTHING OVER THE HEATWRAP AND ATTACHED THE ADHESIVE TO THE BODY. AS OF (B)(6) 2017, THE SYMPTOMS WERE REPORTED AS NOT RESOLVED. THE PATIENT STILL HAD A 2MM WOUND AND MARKS (SCABBY ASPECT). THE PHARMACIST REPORTED THE PATCH WAS NOT APPLIED ON SKIN AND THIS WAS A MISUSE. THE PATIENT'S SKIN WAS ASSESSED AS VERY LIGHT TO FAIR. HE DID NOT ENGAGE IN EXERCISE WHILE USING THE HEATWRAP. THE PATIENT HAD READ THE USAGE INSTRUCTIONS PRIOR TO DEVICE USAGE. HE PREVIOUSLY USED OTHER HEAT PRODUCTS FOR PAIN RELIEF SUCH AS HEATING BAG WITH SEEDS IN (B)(6) 2016 FOR PERIODS OF 30 MINUTES AND THE PATIENT HAD NOT PREVIOUSLY EXPERIENCED A PROBLEM/SYMPTOM WITH ANY OF THESE PRODUCTS. ACTION TAKEN WITH THE SUSPECT PRODUCT WAS UNKNOWN. THERAPEUTIC MEASURES TAKEN INCLUDED DRESSINGS FOR ONE MONTH AND A HALF (NURSE CARES WITH PARAFFIN TULLE, EOSINE AND PADS). CLINICAL OUTCOME OF THE EVENTS WAS NOT RESOLVED. THE PHARMACIST DID NOT SUSPECT A CAUSAL RELATIONSHIP BETWEEN THERMACARE AND THE OCCURRENCE OF THE EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE PROVIDED AS IT BECOMES AVAILABLE. FOLLOW-UP (27JUN2017) : NEW INFORMATION RECEIVED FROM THE CONTACTABLE PHARMACIST INCLUDES: UPDATED PATIENT AGE AND GENDER, PATIENT MEDICAL HISTORY, UPDATED SUSPECT PRODUCT, SUSPECT PRODUCT INDICATION, SUSPECT PRODUCT LOT NUMBER AND EXPIRATION DATE, SUSPECT PRODUCT START DATE, CONCOMITANT MEDICATION, REACTION DATA (UPDATED EVENT THERMAL BURN TO BURNS SECOND DEGREE AND ADDED EVENT INTENTIONAL DEVICE MISUSE), EVENT ONSET DATE, THERAPEUTIC MEASURES TAKEN AND EVENT OUTCOME. THIS CASE HAS BEEN UPGRADED TO A SERIOUS REPORTABLE MEDICAL DEVICE REPORT. AMENDMENT: THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO AMEND PREVIOUSLY REPORTED INFORMATION: UPDATED CONCOMITANT MEDICATION AMOXICILLIN START/STOP DATES AND UPDATED DESCRIPTION TO BE CODED FIELD FROM '2ND DEGREE BURN' TO 'SECOND DEGREE BURNS'. COMPANY CLINICAL EVALUATION COMMENT BASED ON THE INFORMATION PROVIDED, THE EVENTS OF "SECOND DEGREE BURN" "PHARMACIST REPORTED THE PATCH WAS NOT APPLIED ON SKIN AND THIS WAS A MISUSE" AS DESCRIBED ARE CONSIDERED SERIOUS BODILY INJURY POTENTIALLY REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT DAMAGE OR IMPAIRMENT OF BODY STRUCTURE. THE EVENTS OF STILL HAD A 2MM WOUND AND MARKS (SCABBY ASPECT)" ARE NON-SERIOUS. THE EVENTS ARE MEDICALLY ASSESSED AS ASSOCIATED WITH THE USE OF THE DEVICE., COMMENT: BASED ON THE INFORMATION PROVIDED, THE EVENTS OF "SECOND DEGREE BURN" "PHARMACIST REPORTED THE PATCH WAS NOT APPLIED ON SKIN AND THIS WAS A MISUSE" AS DESCRIBED ARE CONSIDERED SERIOUS BODILY INJURY POTENTIALLY REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT DAMAGE OR IMPAIRMENT OF BODY STRUCTURE. THE EVENTS OF STILL HAD A 2MM WOUND AND MARKS (SCABBY ASPECT)" ARE NON-SERIOUS. THE EVENTS ARE MEDICALLY ASSESSED AS ASSOCIATED WITH THE USE OF THE DEVICE.
EVENT VERBATIM [PREFERRED TERM] 2ND DEGREE BURN IN THE LOWER BACK AND WAS BETWEEN 5 AND 10 CM OF LENGTH [BURNS SECOND DEGREE] , WEARING SEVERAL LAYERS OF CLOTHING OVER THE HEATWRAP; PHARMACIST REPORTED THE PATCH WAS NOT APPLIED ON SKIN AND THIS WAS A MISUSE [INTENTIONAL DEVICE MISUSE] , STILL HAD A 2MM WOUND AND MARKS (SCABBY ASPECT) [WOUND] , . CASE NARRATIVE:THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE PHARMACIST AND PHYSICIAN. A (B)(6) MALE PATIENT STARTED TO USE THERMACARE HEATWRAPS (THERMACARE LOWER BACK AND HIP) (DEVICE LOT #: 5190012, EXPIRATION DATE: NOV2020) FOR 6 HOURS FOR LUMBAR PAIN ON (B)(6) 2017. THE PATIENT'S MEDICAL HISTORY INCLUDED CARDIAC DISORDER, CARDIAC ARRHYTHMIA BY ATRIAL FIBRILLATION SINCE 2006, ONGOING, SENSITIVE SKIN FROM AN UNKNOWN DATE AND UNKNOWN IF ONGOING, ARTERIAL HYPERTENSION FROM AN UNKNOWN DATE AND UNKNOWN IF ONGOING, DIABETES FROM AN UNKNOWN DATE AND UNKNOWN IF ONGOING, BLOCKED NOSE FROM AN UNKNOWN DATE AND UNKNOWN IF ONGOING, PULMONARY INFECTION FROM AN UNKNOWN DATE AND UNKNOWN IF ONGOING, THROMBOCYTOPENIA FROM AN UNKNOWN DATE. CONCOMITANT MEDICATIONS INCLUDED ALLOPURINOL (TRADE NAME NOT SPECIFIED) 200, AT 1 INTAKE DAILY, METFORMIN EMBONATE (STAGID) 700, 3 INTAKES DAILY, RIVAROXABAN (XARELTO) 20, AT ONE INTAKE DAILY FOR CARDIAC DISORDERS, CANDESARTAN/HYDROCHLOROTHIAZIDE (TRADE NAME NOT SPECIFIED) 16, AT 1 INTAKE DAILY FOR ARTERIAL HYPERTENSION, ACEBUTOLOL (TRADE NAME NOT SPECIFIED) 200, AT 1 INTAKE DAILY FOR CARDIAC DISORDERS AND MANIDIPINE HYDROCHLORIDE (IPERTEN) 10, AT 1 INTAKE DAILY FOR ARTERIAL HYPERTENSION. THE PATIENT RECEIVED FROM (B)(6) 2017 TO (B)(6) 2017 THE FOLLOWING TREATMENT FOR BLOCKED NOSE AND PULMONARY INFECTION: AMOXICILLINE (TRADE NAME NOT SPECIFIED), TABLETS, TAKEN VIA ORAL ROUTE AT 1G THRICE DAILY, TIXOCORTOL PIVALATE (PIVALONE), NASAL SPRAY, VIA NASAL ROUTE, 2 TO 4 TIMES DAILY AND AMBROXOL (TRADE NAME NOT SPECIFIED), ORAL SOLUTION, TAKEN VIA ORAL ROUTE 5 TO 10ML, TWICE DAILY FOR BLOCKED NOSE AND PULMONARY INFECTION. ON (B)(6) 2017, THE PATIENT USED THE HEATWRAP FOR THE FIRST TIME AND EXPERIENCED A SECOND DEGREE BURN AT 6 PM. THE SECOND DEGREE BURN OCCURRED IN THE LOWER BACK AND WAS BETWEEN 5 AND 10 CM OF LENGTH. THE PATIENT CONSULTED A HEALTHCARE PROFESSIONAL (GENERAL PRACTITIONER) AS A RESULT OF THE BURN. IT WAS REPORTED HE WAS WEARING SEVERAL LAYERS OF CLOTHING OVER THE HEATWRAP AND ATTACHED THE ADHESIVE TO THE BODY. SURGICAL INTERVENTION WAS NOT REQUIRED. ACCORDING TO THE PHYSICIAN, THE PATIENT WOULD NOT EXPERIENCE LONG-TERM SEQUELA SUCH AS SCARRING. THE EVENT WAS CONSIDERED AS NON-SERIOUS ACCORDING TO THE PHYSICIAN. THE PATIENT STILL HAD A 2MM WOUND AND MARKS (SCABBY ASPECT). THE PHARMACIST REPORTED THE PATCH WAS NOT APPLIED ON SKIN AND THIS WAS A MISUSE. THE PATIENT'S SKIN WAS ASSESSED AS VERY LIGHT TO FAIR. HE DID NOT ENGAGE IN EXERCISE WHILE USING THE HEATWRAP. THE PATIENT HAD READ THE USAGE INSTRUCTIONS PRIOR TO DEVICE USAGE. HE PREVIOUSLY USED OTHER HEAT PRODUCTS FOR PAIN RELIEF SUCH AS HEATING BAG WITH SEEDS IN (B)(6) 2016 FOR PERIODS OF 30 MINUTES AND THE PATIENT HAD NOT PREVIOUSLY EXPERIENCED A PROBLEM/SYMPTOM WITH ANY OF THESE PRODUCTS. ACTION TAKEN WITH THE SUSPECT PRODUCT WAS PERMANENTLY WITHDRAWN ON (B)(6) 2017. THERAPEUTIC MEASURES TAKEN INCLUDED DRESSINGS FOR ONE MONTH AND A HALF (NURSE CARES WITH PARAFFIN TULLE, EOSINE AND PADS), VASELINE POMADE APPLICATION FOR SEVERAL DAYS. CLINICAL OUTCOME OF THE EVENT SECOND DEGREE BURN WAS RESOLVED (B)(6) 2017 AND THE OUTCOME OF THE REMAINING EVENTS WAS NOT RESOLVED . THE PHARMACIST DID NOT SUSPECT A CAUSAL RELATIONSHIP BETWEEN THERMACARE AND THE OCCURRENCE OF THE EVENT. THE PHYSICIAN CONSIDERED THE EVENT OF SECOND DEGREE BURNS AS RELATED TO THERMACARE HEATWRAPS. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE PROVIDED AS IT BECOMES AVAILABLE. FOLLOW-UP (27JUN2017): NEW INFORMATION RECEIVED FROM THE CONTACTABLE PHARMACIST INCLUDES: UPDATED PATIENT AGE AND GENDER, PATIENT MEDICAL HISTORY, UPDATED SUSPECT PRODUCT, SUSPECT PRODUCT INDICATION, SUSPECT PRODUCT LOT NUMBER AND EXPIRATION DATE, SUSPECT PRODUCT START DATE, CONCOMITANT MEDICATION, REACTION DATA (UPDATED EVENT THERMAL BURN TO BURNS SECOND DEGREE AND ADDED EVENT INTENTIONAL DEVICE MISUSE), EVENT ONSET DATE, THERAPEUTIC MEASURES TAKEN AND EVENT OUTCOME. THIS CASE HAS BEEN UPGRADED TO A SERIOUS REPORTABLE MEDICAL DEVICE REPORT. AMENDMENT: THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO AMEND PREVIOUSLY REPORTED INFORMATION: UPDATED CONCOMITANT MEDICATION AMOXICILLIN START/STOP DATES AND UPDATED DESCRIPTION TO BE CODED FIELD FROM '2ND DEGREE BURN' TO 'SECOND DEGREE BURNS'. FOLLOW-UP (11AUG2017): NEW INFORMATION RECEIVED FROM A CONTACTABLE PHYSICIAN INCLUDED MEDICAL HISTORY, PRODUCT DATA (UPDATED START/STOP DATES, ACTION TAKEN), REACTION DATA (UPDATED ONSET DATE, EVENT VERBATIM DESCRIPTION, TREATMENT, OUTCOME, SERIOUSNESS AND CAUSALITY ASSESSMENT). COMPANY CLINICAL EVALUATION COMMENT BASED ON THE INFORMATION PROVIDED, THE EVENTS OF "SECOND DEGREE BURN" "PHARMACIST REPORTED THE PATCH WAS NOT APPLIED ON SKIN AND THIS WAS A MISUSE" AS DESCRIBED ARE CONSIDERED SERIOUS BODILY INJURY POTENTIALLY REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT DAMAGE OR IMPAIRMENT OF BODY STRUCTURE. THE EVENTS OF STILL HAD A 2MM WOUND AND MARKS (SCABBY ASPECT)" ARE NON-SERIOUS. THE EVENTS ARE MEDICALLY ASSESSED AS ASSOCIATED WITH THE USE OF THE DEVICE., COMMENT: BASED ON THE INFORMATION PROVIDED, THE EVENTS OF "SECOND DEGREE BURN" "PHARMACIST REPORTED THE PATCH WAS NOT APPLIED ON SKIN AND THIS WAS A MISUSE" AS DESCRIBED ARE CONSIDERED SERIOUS BODILY INJURY POTENTIALLY REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT DAMAGE OR IMPAIRMENT OF BODY STRUCTURE. THE EVENTS OF STILL HAD A 2MM WOUND AND MARKS (SCABBY ASPECT)" ARE NON-SERIOUS. THE EVENTS ARE MEDICALLY ASSESSED AS ASSOCIATED WITH THE USE OF THE DEVICE.
EVENT VERBATIM [PREFERRED TERM] 2ND DEGREE BURN IN THE LOWER BACK AND WAS BETWEEN 5 AND 10 CM OF LENGTH, HAD A 2MM WOUND AND MARKS (SCABBY ASPECT) [BURNS SECOND DEGREE] , ATTACHED THE HEATWRAP DIRECTLY TO THE BODY AND HAD READ THE USAGE INSTRUCTIONS PRIOR TO USE [INTENTIONAL DEVICE MISUSE]. CASE NARRATIVE:THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE PHARMACIST AND PHYSICIAN. A (B)(6) MALE PATIENT STARTED TO USE THERMACARE HEATWRAPS (THERMACARE LOWER BACK AND HIP) (DEVICE LOT #: 5190012, EXPIRATION DATE: NOV2020) (LOT NUMBER INVALID) FOR 6 HOURS FOR LUMBAR PAIN ON (B)(6) 2017. THE PATIENT'S MEDICAL HISTORY INCLUDED CARDIAC DISORDER, CARDIAC ARRHYTHMIA BY ATRIAL FIBRILLATION SINCE 2006, ONGOING, SENSITIVE SKIN FROM AN UNKNOWN DATE AND UNKNOWN IF ONGOING, ARTERIAL HYPERTENSION FROM AN UNKNOWN DATE AND UNKNOWN IF ONGOING, DIABETES FROM AN UNKNOWN DATE AND UNKNOWN IF ONGOING, BLOCKED NOSE FROM AN UNKNOWN DATE AND UNKNOWN IF ONGOING, PULMONARY INFECTION FROM AN UNKNOWN DATE AND UNKNOWN IF ONGOING, THROMBOCYTOPENIA FROM AN UNKNOWN DATE. CONCOMITANT MEDICATIONS INCLUDED ALLOPURINOL (TRADE NAME NOT SPECIFIED) 200, AT 1 INTAKE DAILY, METFORMIN EMBONATE (STAGID) 700, 3 INTAKES DAILY, RIVAROXABAN (XARELTO) 20, AT ONE INTAKE DAILY FOR CARDIAC DISORDERS, CANDESARTAN/HYDROCHLOROTHIAZIDE (TRADE NAME NOT SPECIFIED) 16, AT 1 INTAKE DAILY FOR ARTERIAL HYPERTENSION, ACEBUTOLOL (TRADE NAME NOT SPECIFIED) 200, AT 1 INTAKE DAILY FOR CARDIAC DISORDERS AND MANIDIPINE HYDROCHLORIDE (IPERTEN) 10, AT 1 INTAKE DAILY FOR ARTERIAL HYPERTENSION. THE PATIENT RECEIVED FROM (B)(6) 2017 THE FOLLOWING TREATMENT FOR BLOCKED NOSE AND PULMONARY INFECTION: AMOXICILLINE (TRADE NAME NOT SPECIFIED), TABLETS, TAKEN VIA ORAL ROUTE AT 1G THRICE DAILY, TIXOCORTOL PIVALATE (PIVALONE), NASAL SPRAY, VIA NASAL ROUTE, 2 TO 4 TIMES DAILY AND AMBROXOL (TRADE NAME NOT SPECIFIED), ORAL SOLUTION, TAKEN VIA ORAL ROUTE 5 TO 10ML, TWICE DAILY FOR BLOCKED NOSE AND PULMONARY INFECTION. ON (B)(6) 2017, THE PATIENT USED THE HEATWRAP FOR THE FIRST TIME AND EXPERIENCED A SECOND DEGREE BURN AT 6 PM. THE SECOND DEGREE BURN OCCURRED IN THE LOWER BACK AND WAS BETWEEN 5 AND 10 CM OF LENGTH. THE PATIENT CONSULTED A HEALTHCARE PROFESSIONAL (GENERAL PRACTITIONER) AS A RESULT OF THE BURN. IT WAS REPORTED HE WAS WEARING SEVERAL LAYERS OF CLOTHING OVER THE HEATWRAP AND ATTACHED THE HEATWRAP DIRECTLY TO THE BODY. SURGICAL INTERVENTION WAS NOT REQUIRED. ACCORDING TO THE PHYSICIAN, THE PATIENT WOULD NOT EXPERIENCE LONG-TERM SEQUELA SUCH AS SCARRING. THE EVENT WAS CONSIDERED AS NON-SERIOUS ACCORDING TO THE PHYSICIAN. THE PATIENT STILL HAD A 2MM WOUND AND MARKS (SCABBY ASPECT). THE PHARMACIST REPORTED THE PATCH WAS APPLIED DIRECTLY TO THE PATIENT'S SKIN, WHICH WAS A MISUSE CONSIDERING THE PATIENT'S AGE. THE PATIENT'S SKIN WAS ASSESSED AS VERY LIGHT TO FAIR. HE DID NOT ENGAGE IN EXERCISE WHILE USING THE HEATWRAP. THE PATIENT HAD READ THE USAGE INSTRUCTIONS PRIOR TO DEVICE USAGE. HE PREVIOUSLY USED OTHER HEAT PRODUCTS FOR PAIN RELIEF SUCH AS HEATING BAG WITH SEEDS IN (B)(6) 2016 FOR PERIODS OF 30 MINUTES AND THE PATIENT HAD NOT PREVIOUSLY EXPERIENCED A PROBLEM/SYMPTOM WITH ANY OF THESE PRODUCTS. ACTION TAKEN WITH THE SUSPECT PRODUCT WAS PERMANENTLY WITHDRAWN ON (B)(6) 2017. THERAPEUTIC MEASURES TAKEN INCLUDED DRESSINGS FOR ONE MONTH AND A HALF (NURSE CARES WITH PARAFFIN TULLE, EOSINE AND PADS), VASELLINE POMADE APPLICATION FOR SEVERAL DAYS. CLINICAL OUTCOME OF THE EVENT SECOND DEGREE BURN WAS RESOLVED (B)(6) 2017 AND THE OUTCOME OF THE REMAINING EVENT WAS UNKNOWN. THE PHARMACIST DID NOT SUSPECT A CAUSAL RELATIONSHIP BETWEEN THERMACARE AND THE OCCURRENCE OF THE EVENT. THE PHYSICIAN CONSIDERED THE EVENT OF SECOND DEGREE BURNS AS RELATED TO THERMACARE HEATWRAPS. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE PROVIDED AS IT BECOMES AVAILABLE. FOLLOW-UP (27JUN2017): NEW INFORMATION RECEIVED FROM THE CONTACTABLE PHARMACIST INCLUDES: UPDATED PATIENT AGE AND GENDER, PATIENT MEDICAL HISTORY, UPDATED SUSPECT PRODUCT, SUSPECT PRODUCT INDICATION, SUSPECT PRODUCT LOT NUMBER AND EXPIRATION DATE, SUSPECT PRODUCT START DATE, CONCOMITANT MEDICATION, REACTION DATA (UPDATED EVENT THERMAL BURN TO BURNS SECOND DEGREE AND ADDED EVENT INTENTIONAL DEVICE MISUSE), EVENT ONSET DATE, THERAPEUTIC MEASURES TAKEN AND EVENT OUTCOME. THIS CASE HAS BEEN UPGRADED TO A SERIOUS REPORTABLE MEDICAL DEVICE REPORT. AMENDMENT: THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO AMEND PREVIOUSLY REPORTED INFORMATION: UPDATED CONCOMITANT MEDICATION AMOXICILLIN START/STOP DATES AND UPDATED DESCRIPTION TO BE CODED FIELD FROM '2ND DEGREE BURN' TO 'SECOND DEGREE BURNS'. FOLLOW-UP (11AUG2017): NEW INFORMATION RECEIVED FROM A CONTACTABLE PHYSICIAN INCLUDED MEDICAL HISTORY, PRODUCT DATA (UPDATED START/STOP DATES, ACTION TAKEN), REACTION DATA (UPDATED ONSET DATE, EVENT VERBATIM DESCRIPTION, TREATMENT, OUTCOME, SERIOUSNESS AND CAUSALITY ASSESSMENT). FOLLOW-UP (05JUL2017): THIS FOLLOW-UP IS BEING SUBMITTED TO NOTIFY THAT AN INVESTIGATION OF THE DEVICE CANNOT BE CONDUCTED. THE LOCAL PRODUCT QUALITY GROUP CONFIRMED THE LOT NUMBER WAS INVALID AND IT WAS NOT POSSIBLE TO RETRIEVE IT AS THE SAMPLE HAS BEEN DISCARDED. UPDATED REACTION DATA (SUBSUMED EVENT WOUND UNDER EVENT SECOND DEGREE BURN. FOLLOW-UP ATTEMPTS HAVE BEEN COMPLETED AND NO FURTHER INFORMATION IS EXPECTED. FOLLOW-UP (06OCT2017): NEW INFORMATION WAS PROVIDED BY THE CONTACTABLE PHARMACIST WHO CONFIRMED THERMACARE HEATWRAP WAS DIRECTLY APPLIED ON THE PATIENT'S SKIN (WHICH WAS A MISUSE CONSIDERING THE PATIENT'S AGE). FOLLOW-UP ATTEMPTS COMPLETED, NO FURTHER INFORMATION EXPECTED., COMMENT: BASED ON THE INFORMATION PROVIDED, THE EVENTS OF "SECOND DEGREE BURN"/"INTENTIONAL DEVICE MISUSE" ARE CONSIDERED SERIOUS BODILY INJURY 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 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 |
|---|---|---|---|---|---|---|---|
| 477164 | THERMACARE LOWER BACK & HIP | DISPOSABLE PACK, HOT | IMD | PFIZER CONSUMER HEALTH CARE | 5190012 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Required Intervention | ACEBUTOLOL.| ACEBUTOLOL.| ACEBUTOLOL.| ACEBUTOLOL.| ACEBUTOLOL.| ALLOPURINOL.| ALLOPURINOL.| ALLOPURINOL.| ALLOPURINOL.| ALLOPURINOL.| AMBROXOL.| AMBROXOL.| AMBROXOL.| AMBROXOL.| AMBROXOL.| AMBROXOL.| AMBROXOL.| AMBROXOL.| AMBROXOL.| AMBROXOL.| AMOXICILLIN.| AMOXICILLIN.| AMOXICILLIN.| AMOXICILLIN.| AMOXICILLIN.| AMOXICILLIN.| AMOXICILLIN.| AMOXICILLIN.| AMOXICILLIN.| AMOXICILLIN.| CANDESARTAN+HYDROCHLOROTHIAZIDE.| CANDESARTAN+HYDROCHLOROTHIAZIDE.| CANDESARTAN+HYDROCHLOROTHIAZIDE.| CANDESARTAN+HYDROCHLOROTHIAZIDE.| CANDESARTAN+HYDROCHLOROTHIAZIDE.| IPERTEN.| IPERTEN.| IPERTEN.| IPERTEN.| IPERTEN.| PIVALONE /00803802/.| PIVALONE /00803802/.| PIVALONE /00803802/.| PIVALONE /00803802/.| PIVALONE /00803802/.| PIVALONE /00803802/.| PIVALONE /00803802/.| PIVALONE /00803802/.| PIVALONE [TIXOCORTOL PIVALATE].| PIVALONE [TIXOCORTOL PIVALATE].| STAGID.| STAGID.| STAGID.| STAGID.| STAGID.| VASELINE /00473501/.| VASELINE /00473501/.| VASELINE /00473501/.| VASELINE /00473501/.| XARELTO.| XARELTO.| XARELTO.| XARELTO.| XARELTO.| ACEBUTOLOL| ALLOPURINOL| AMBROXOL| AMBROXOL| AMOXICILLIN| AMOXICILLIN| CANDESARTAN+HYDROCHLOROTHIAZIDE| IPERTEN| PIVALONE /(B)(4)/| PIVALONE /(B)(4)/| STAGID| VASELINE /(B)(4)/| VASELINE /(B)(4)/| XARELTO |