BIOTENE ORAL BALANCE GEL
Report
- Report Number
- 3012293198-2018-00004
- Event Type
- Death
- Date Received
- May 31, 2018
- Manufacturer
- ULTRADENT PRODUCTS INC/ORATECH LLC
- Product Code
- LFD
- PMA / PMN Number
- K123731
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
INITIAL REPORT FILED UNDER MANUFACTURER NUMBER (B)(4) THIS NUMBER HAS SINCE BEEN CHANGED TO (B)(4). ALL FOLLOW UP REPORTS WILL BE SUBMITTED UNDER THE CURRENT MANUFACTURER NUMBER OF (B)(4). 3012293198-2018-00004 IS ASSOCIATED WITH ARGUS CASE (B)(4) BIOTENE ORAL BALANCE GEL. DEVICE EVALUATION (COMPLAINT NUMBER (B)(4)) ON 15 MAY 2018: BATCH REVIEW SHOWS NO DEVIATIONS OR QUALITY REMARKS. THE PRODUCT WAS PRODUCED ACCORDING TO THE SPECIFICATIONS. REVIEW OF ANALYTICAL TESTS SHOWS RESULTS CONFORM TO THE SPECIFICATIONS. THE PRODUCT IS NOT SUSPECTED TO HAVE BEEN CONTRIBUTORY TO THE CAUSE OF THE INCIDENT. CONCLUSION: NON-CONFIRMED. THE PRODUCT WAS PRODUCED ACCORDING TO THE SPECIFICATIONS. IT IS NOT SUSPECTED TO HAVE BEEN CONTRIBUTORY TO THE STATE OF HEALTH OF THE PATIENT.
1718912-2018-00005 IS ASSOCIATED WITH ARGUS CASE: (B)(4), BIOTENE ORAL BALANCE GEL. INITIAL REPORT FILED UNDER MANUFACTURER NUMBER: 1718912, THIS NUMBER HAS SINCE BEEN CHANGED TO 3012293198. ALL FOLLOW UP REPORTS WILL BE SUBMITTED UNDER THE CURRENT MANUFACTURER NUMBER OF 3012293198. ASSOCIATED WITH ARGUS CASE: (B)(4) BIOTENE ORAL BALANCE GEL. DEVICE EVALUATION (COMPLAINT NUMBER: (B)(4)) ON 15 MAY 2018: BATCH REVIEW SHOWS NO DEVIATIONS OR QUALITY REMARKS. THE PRODUCT WAS PRODUCED ACCORDING TO THE SPECIFICATIONS. REVIEW OF ANALYTICAL TESTS SHOWS RESULTS CONFORM TO THE SPECIFICATIONS. THE PRODUCT IS NOT SUSPECTED TO HAVE BEEN CONTRIBUTORY TO THE CAUSE OF THE INCIDENT. CONCLUSION: NON-CONFIRMED. THE PRODUCT WAS PRODUCED ACCORDING TO THE SPECIFICATIONS. IT IS NOT SUSPECTED TO HAVE BEEN CONTRIBUTORY TO THE STATE OF HEALTH OF THE PATIENT.
DEATH [DEATH]. NEAR SUFFOCATION / EXPERIENCED INCREASING DYSPNEA [SUFFOCATION]. GEL ENTERED THE LUNGS / BIOTENE ORAL BALANCE GEL WAS FOUND IN THE LUNG [ASPIRATION]. A SPUTUM PLUG WAS THOUGHT TO CAUSE THIS [SPUTUM]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF SUFFOCATION IN A PATIENT WHO RECEIVED GLYCERIN (BIOTENE ORAL BALANCE GEL) GEL FOR DRUG USE FOR UNKNOWN INDICATION. ON AN UNKNOWN DATE, THE PATIENT STARTED BIOTENE ORAL BALANCE GEL. ON (B)(6) 2018, AN UNKNOWN TIME AFTER STARTING BIOTENE ORAL BALANCE GEL, THE PATIENT EXPERIENCED SUFFOCATION (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT AND LIFE THREATENING). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FOREIGN BODY IN RESPIRATORY TRACT. BIOTENE ORAL BALANCE GEL WAS DISCONTINUED (DECHALLENGE WAS UNKNOWN). ON AN UNKNOWN DATE, THE OUTCOME OF THE SUFFOCATION WAS NOT REPORTED AND THE OUTCOME OF THE FOREIGN BODY IN RESPIRATORY TRACT WAS UNKNOWN. THE REPORTER CONSIDERED THE SUFFOCATION TO BE PROBABLY RELATED TO BIOTENE ORAL BALANCE GEL. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE FOREIGN BODY IN RESPIRATORY TRACT TO BE RELATED TO BIOTENE ORAL BALANCE GEL. THIS REPORT IS MADE BY GSK WITHOUT PREJUDICE AND DOES NOT IMPLY ANY ADMISSION OR LIABILITY FOR THE INCIDENT OR ITS CONSEQUENCES. ADDITIONAL DETAILS: THIS CASE WAS REPORTED BY A WHOLESALER EMPLOYEE, WHO RECEIVED THIS CASE FROM A HOSPITAL. (B)(6) 2018 THE PATIENT NEARLY SUFFOCATED DUE TO BIOTENE ORAL BALANCE GEL, THE GEL ENTERED THE LUNGS OF THE PATIENT. THE FOLLOWING BATCH NUMBERS WERE RETURNED TO THE WHOLESALER BY THE HOSPITAL: 101199, 5144526 (EXPIRY DATE: APR-2020), 5144966 (EXPIRY DATE: AUG-2020). FOLLOW UP WAS RECEIVED ON 29 MAR 2018: THIS CASE WAS REGARDING BATCH NUMBER 5144526, EXPIRY DATE APRIL 2020. THE REPORTER CONSIDERED THE SUFFOCATION TO BE RELATED TO BIOTENE ORAL BALANCE GEL. FOLLOW UP WAS RECEIVED ON 01 MAY 2018 THIS CASE WAS REPORTED BY A PHYSICIAN AND DESCRIBED THE OCCURRENCE OF DEATH IN A 78-YEAR-OLD MALE PATIENT WHO RECEIVED GLYCERIN (BIOTENE ORAL BALANCE GEL) GEL (BATCH NUMBER 5144526, EXPIRY DATE APRIL 2020) FOR DRY MOUTH. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED POLYMYALGIA RHEUMATICA (ADMITTED TO THE HOSPITAL ON (B)(6)2018), NON ST SEGMENT ELEVATION MYOCARDIAL INFARCTION, UROSEPSIS, CHRONIC RENAL FAILURE WORSENED AND PERCUTANEOUS CORONARY INTERVENTION. CONCURRENT MEDICAL CONDITIONS INCLUDED DYSPHAGIA, LARYNGEAL DISCOMFORT AND FEEDING TUBE USER. ON (B)(6) 2018, THE PATIENT STARTED BIOTENE ORAL BALANCE GEL. ON (B)(6) 2018, 1 DAYS AFTER STARTING BIOTENE ORAL BALANCE GEL, THE PATIENT EXPERIENCED SUFFOCATION (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT, LIFE THREATENING AND OTHER: GSK MEDICALLY SIGNIFICANT). ON (B)(6) 2018, THE PATIENT EXPERIENCED DEATH (SERIOUS CRITERIA DEATH AND GSK MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ASPIRATION (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT) AND SPUTUM. ON AN UNKNOWN DATE, THE OUTCOME OF THE DEATH WAS FATAL AND THE OUTCOME OF THE SUFFOCATION WAS RECOVERED/RESOLVED AND THE OUTCOME OF THE ASPIRATION AND SPUTUM WERE UNKNOWN. THE PATIENT DIED ON (B)(6) 2018. THE REPORTED CAUSE OF DEATH WAS UNKNOWN CAUSE OF DEATH. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE DEATH, ASPIRATION AND SPUTUM TO BE RELATED TO BIOTENE ORAL BALANCE GEL. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2018 DUE POLYMYALGIA RHEUMATICA, NON-ST-ELEVATION-MYOCARDIAL INFARCTION (NSTEMI) FOR WHICH PERCUTANEOUS CORONARY INTERVENTION (PCI) OF THE RAMUS CIRCUMFLEX (RCX) (2017), SEPSIS DIFFERENTIAL DIAGNOSIS UROSEPSIS AND WORSENING WITH CHRONIC RENAL INSUFFICIENCY. PATIENT DID NOT RECEIVE ANYTHING ORALLY. AFTER PATIENT EXPERIENCED INCREASING DYSPNEA ON (B)(6) 2018, AND A SPUTUM PLUG WAS THOUGHT TO CAUSE THIS, THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT. THE LUNG WAS FLUSHED AND A SCOPY WAS DONE. BIOTENE ORAL BALANCE GEL WAS FOUND IN THE LUNG. THE PULMONOLOGIST COULD NOT REMOVE IT ALL DURING THE BRONCHOSCOPY. THEREFORE, THE PATIENT WAS TRANSFERRED TO AN ACADEMIC HOSPITAL, WHERE THE REMAINS OF THE BIOTENE ORAL BALANCE GEL WERE REMOVED. THE PATIENT WAS TRANSFERRED BACK TO THE ORIGINAL HOSPITAL THEREAFTER. IT WAS UNCLEAR WHETHER THE INCIDENT WITH THE BIOTENE ORAL BALANCE GEL (B)(6) 2018 CONTRIBUTED TO THE PATIENT'S DEATH. PATIENT DETAILS UPDATED. NO NEW MEDICALLY RELEVANT INFORMATION WAS RECEIVED ON 09 MAY 2018. FOLLOW UP INFORMATION RECEIVED FROM QUALITY ASSURANCE DEPARTMENT ON 15 MAY 2018 THIS CASE WAS ASSOCIATED WITH A PRODUCT COMPLAINT. QUALITY ASSURANCE ANALYSIS REVEALED THAT THE PRODUCT WAS NOT SUSPECTED TO HAVE BEEN CONTRIBUTED TO THE CAUSE OF THE INCIDENT. ALTERNATIVE CAUSES FOR THE EVENTS AND DEATH SHOULD BE CONSIDERED IN THE UNWELL PATIENT WITH A HISTORY OF SEPSIS AND MYOCARDIAL INFARCTION. THE PRODUCT WAS PRODUCED ACCORDING TO THE SPECIFICATIONS. IT WAS NOT SUSPECTED TO HAVE BEEN CONTRIBUTORY TO THE STATE OF HEALTH OF THE PATIENT. FOLLOW UP INFORMATION RECEIVED FROM THE PHYSICIAN ON 24 MAY 2018: THE REPORTER STATED THAT IN 2018 A ENT PHYSICIAN ANALYZED THE PATIENT DUE TO CHOKING, NO INDICATION FOR ENT-RELATED PROBLEMS INTERPRETED AS FUNCTIONAL. FURTHER INDICATION OF OSAS (OBSTRUCTIVE SLEEP APNEU SYNDROME). PATIENT STATED THAT HE HAD TROUBLE WITH SWALLOWING SINCE 2 WEEKS AND CHOKES QUICKLY/OFTEN. INCREASING DIFFICULTY SPEAKING, IT FELT LIKE A HOT POTATO WAS IN HIS THROAT. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2018 DUE TO POLYMYALGIA RHEUMATICA, NON ST ELEVATION MYOCARDIAL INFARCTION (NSTEMI) FOR WHICH PERCUTANEOUS CORONARY INTERVENTION (PCI) OF THE RAMUS CIRCUMFLEX (RCX) (2017), SEPSIS DIFFERENTIAL DIAGNOSIS UROSEPSIS AND WORSENING WITH CHRONIC RENAL INSUFFICIENCY. ALSO SEVERE DYSFALGIA, BARELY LARYNGEAL RAISING AND FATIGUE. THEREFORE THE POLICY WAS TO NOT ADMINISTER ANYTHING ORALLY. THE PATIENT RECEIVED TUBE FEEDING VIA A STOMACH TUBE. SINCE (B)(6) 2018 THE PATIENT WAS INCREASINGLY CONFUSED/DELIRIC. AT (B)(6) 2018 THE PATIENT WAS TAKEN TO THE INTENSIVE CARE UNIT DUE TO RESPIRATORY INSUFFICIENCIES AND A BRONCHOSCOPY WAS PERFORMED. A CORPUS ALIENUM WAS DISCOVERED IN THE PATIENTS RIGHT LUNG. THE LUNG PHYSICIAN REPORTED INTRODUCTION VIA TUBE, GOOD VIEW, ENTIRE BRONCHIAL SYSTEM EASY TO SEE. RIGHT, IN THE STEM BRONCHUS A LARGE CLUMP BLACK GREY MATERIAL THAT CLOSED THE RIGHT LOWER LOBE AND THE RIGHT MIDDLE LOBE ENTIRELY. THE MATERIAL HAD THE CONSISTENCY OF GEL, WAS CLEARLY FOREIGN AND WAS BLACK GREY WITH A SHINY SURFACE. IT WAS NOT POSSIBLE TO REMOVE THE MATERIAL VIA SUCTION. MULTIPLE ATTEMPTS WERE MADE WITH VARIOUS TOOLS TO REMOVE THE MATERIAL. IT WAS ONLY POSSIBLE TO REMOVE SMALL PARTS OF THE MATERIAL, BUT MORE THEN HALF OF THE MATERIAL REMAINED. THE RIGHT BRONCHIAL SYSTEM WAS AFTER REMOVAL OF THE MATERIAL COMPLETELY NORMAL. PATIENT REMAINED RESPIRATORY INSUFFICIENT. AFTER 2 HOURS (WITH MULTIPLE INTERRUPTIONS) THE PROCEDURE WAS DISCONTINUED. PATIENT DIED AT (B)(6) 2018. THERE WAS PERMISSION TO CONDUCT AN AUTOPSY. THE AUTOPSY REPORT WAS NOT YET FINAL.
CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF SUFFOCATION IN A PATIENT WHO RECEIVED GLYCERIN (BIOTENE ORAL BALANCE GEL) GEL FOR DRUG USE FOR UNKNOWN INDICATION. ON AN UNKNOWN DATE, THE PATIENT STARTED BIOTENE ORAL BALANCE GEL. ON (B)(6) 2018, AN UNKNOWN TIME AFTER STARTING BIOTENE ORAL BALANCE GEL, THE PATIENT EXPERIENCED SUFFOCATION (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT AND LIFE THREATENING). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FOREIGN BODY IN RESPIRATORY TRACT. BIOTENE ORAL BALANCE GEL WAS DISCONTINUED (DECHALLENGE WAS UNKNOWN). ON AN UNKNOWN DATE, THE OUTCOME OF THE SUFFOCATION WAS NOT REPORTED AND THE OUTCOME OF THE FOREIGN BODY IN RESPIRATORY TRACT WAS UNKNOWN. THE REPORTER CONSIDERED THE SUFFOCATION TO BE PROBABLY RELATED TO BIOTENE ORAL BALANCE GEL. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE FOREIGN BODY IN RESPIRATORY TRACT TO BE RELATED TO BIOTENE ORAL BALANCE GEL. THIS REPORT IS MADE BY GSK WITHOUT PREJUDICE AND DOES NOT IMPLY ANY ADMISSION OR LIABILITY FOR THE INCIDENT OR ITS CONSEQUENCES. ADDITIONAL DETAILS: THIS CASE WAS REPORTED BY A WHOLESALER EMPLOYEE, WHO RECEIVED THIS CASE FROM A HOSPITAL. ON (B)(6) 2018 THE PATIENT NEARLY SUFFOCATED DUE TO BIOTENE ORAL BALANCE GEL, THE GEL ENTERED THE LUNGS OF THE PATIENT. THE FOLLOWING BATCH NUMBERS WERE RETURNED TO THE WHOLESALER BY THE HOSPITAL: 101199, 5144526 (EXPIRY DATE: APR-2020), 5144966 (EXPIRY DATE: AUG-2020). FOLLOW UP WAS RECEIVED ON 29 MAR 2018: THIS CASE WAS REGARDING BATCH NUMBER: 5144526, EXPIRY DATE: APRIL 2020. THE REPORTER CONSIDERED THE SUFFOCATION TO BE RELATED TO BIOTENE ORAL BALANCE GEL. FOLLOW UP WAS RECEIVED ON 01 MAY 2018. THIS CASE WAS REPORTED BY A PHYSICIAN AND DESCRIBED THE OCCURRENCE OF DEATH IN A 78-YEAR-OLD MALE PATIENT WHO RECEIVED GLYCERIN (BIOTENE ORAL BALANCE GEL) GEL (BATCH NUMBER: 5144526, EXPIRY DATE: APRIL 2020) FOR DRY MOUTH. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED POLYMYALGIA RHEUMATICA (ADMITTED TO THE HOSPITAL ON (B)(6) 2018), NON ST SEGMENT ELEVATION MYOCARDIAL INFARCTION, UROSEPSIS, CHRONIC RENAL FAILURE WORSENED AND PERCUTANEOUS CORONARY INTERVENTION. CONCURRENT MEDICAL CONDITIONS INCLUDED DYSPHAGIA, LARYNGEAL DISCOMFORT AND FEEDING TUBE USER. ON (B)(6) 2018, THE PATIENT STARTED BIOTENE ORAL BALANCE GEL. ON (B)(6) 2018, 1 DAYS AFTER STARTING BIOTENE ORAL BALANCE GEL, THE PATIENT EXPERIENCED SUFFOCATION (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT, LIFE THREATENING AND OTHER: GSK MEDICALLY SIGNIFICANT). ON (B)(6) 2018, THE PATIENT EXPERIENCED DEATH (SERIOUS CRITERIA DEATH AND GSK MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ASPIRATION (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT) AND SPUTUM. ON AN UNKNOWN DATE, THE OUTCOME OF THE DEATH WAS FATAL AND THE OUTCOME OF THE SUFFOCATION WAS RECOVERED/RESOLVED AND THE OUTCOME OF THE ASPIRATION AND SPUTUM WERE UNKNOWN. THE PATIENT DIED ON (B)(6) 2018. THE REPORTED CAUSE OF DEATH WAS UNKNOWN CAUSE OF DEATH. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE DEATH, ASPIRATION AND SPUTUM TO BE RELATED TO BIOTENE ORAL BALANCE GEL. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2018 DUE POLYMYALGIA RHEUMATICA, NON-ST-ELEVATION-MYOCARDIAL INFARCTION (NSTEMI) FOR WHICH PERCUTANEOUS CORONARY INTERVENTION (PCI) OF THE RAMUS CIRCUMFLEX (RCX) (2017), SEPSIS DIFFERENTIAL DIAGNOSIS UROSEPSIS AND WORSENING WITH CHRONIC RENAL INSUFFICIENCY. PATIENT DID NOT RECEIVE ANYTHING ORALLY. AFTER PATIENT EXPERIENCED INCREASING DYSPNEA ON (B)(6) 2018, AND A SPUTUM PLUG WAS THOUGHT TO CAUSE THIS, THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT. THE LUNG WAS FLUSHED AND A SCOPY WAS DONE. BIOTENE ORAL BALANCE GEL WAS FOUND IN THE LUNG. THE PULMONOLOGIST COULD NOT REMOVE IT ALL DURING THE BRONCHOSCOPY. THEREFORE, THE PATIENT WAS TRANSFERRED TO AN ACADEMIC HOSPITAL, WHERE THE REMAINS OF THE BIOTENE ORAL BALANCE GEL WERE REMOVED. THE PATIENT WAS TRANSFERRED BACK TO THE ORIGINAL HOSPITAL THEREAFTER. IT WAS UNCLEAR WHETHER THE INCIDENT WITH THE BIOTENE ORAL BALANCE GEL ON (B)(6) 2018 CONTRIBUTED TO THE PATIENT'S DEATH. PATIENT DETAILS UPDATED. NO NEW MEDICALLY RELEVANT INFORMATION WAS RECEIVED ON 09 MAY 2018. FOLLOW UP INFORMATION RECEIVED FROM QUALITY ASSURANCE DEPARTMENT ON 15 MAY 2018 THIS CASE WAS ASSOCIATED WITH A PRODUCT COMPLAINT. QUALITY ASSURANCE ANALYSIS REVEALED THAT THE PRODUCT WAS NOT SUSPECTED TO HAVE BEEN CONTRIBUTED TO THE CAUSE OF THE INCIDENT. ALTERNATIVE CAUSES FOR THE EVENTS AND DEATH SHOULD BE CONSIDERED IN THE UNWELL PATIENT WITH A HISTORY OF SEPSIS AND MYOCARDIAL INFARCTION. THE PRODUCT WAS PRODUCED ACCORDING TO THE SPECIFICATIONS. IT WAS NOT SUSPECTED TO HAVE BEEN CONTRIBUTORY TO THE STATE OF HEALTH OF THE PATIENT. FOLLOW UP INFORMATION RECEIVED FROM THE PHYSICIAN ON 24 MAY 2018: THE REPORTER STATED THAT IN 2018 A ENT PHYSICIAN ANALYZED THE PATIENT DUE TO CHOKING, NO INDICATION FOR ENT-RELATED PROBLEMS INTERPRETED AS FUNCTIONAL. FURTHER INDICATION OF OSAS (OBSTRUCTIVE SLEEP APNEU SYNDROME). PATIENT STATED THAT HE HAD TROUBLE WITH SWALLOWING SINCE 2 WEEKS AND CHOKES QUICKLY/OFTEN. INCREASING DIFFICULTY SPEAKING, IT FELT LIKE A HOT POTATO WAS IN HIS THROAT. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6)2018 DUE TO POLYMYALGIA RHEUMATICA, NON ST ELEVATION MYOCARDIAL INFARCTION (NSTEMI) FOR WHICH PERCUTANEOUS CORONARY INTERVENTION (PCI) OF THE RAMUS CIRCUMFLEX (RCX) (2017), SEPSIS DIFFERENTIAL DIAGNOSIS UROSEPSIS AND WORSENING WITH CHRONIC RENAL INSUFFICIENCY. ALSO SEVERE DYSFALGIA, BARELY LARYNGEAL RAISING AND FATIGUE. THEREFORE THE POLICY WAS TO NOT ADMINISTER ANYTHING ORALLY. THE PATIENT RECEIVED TUBE FEEDING VIA A STOMACH TUBE. SINCE ON (B)(6) 2018 THE PATIENT WAS INCREASINGLY CONFUSED/DELIRIC. ON (B)(6) 2018 THE PATIENT WAS TAKEN TO THE INTENSIVE CARE UNIT DUE TO RESPIRATORY INSUFFICIENCIES AND A BRONCHOSCOPY WAS PERFORMED. A CORPUS ALIENUM WAS DISCOVERED IN THE PATIENTS RIGHT LUNG. THE LUNG PHYSICIAN REPORTED INTRODUCTION VIA TUBE, GOOD VIEW, ENTIRE BRONCHIAL SYSTEM EASY TO SEE. RIGHT, IN THE STEM BRONCHUS A LARGE CLUMP BLACK GREY MATERIAL THAT CLOSED THE RIGHT LOWER LOBE AND THE RIGHT MIDDLE LOBE ENTIRELY. THE MATERIAL HAD THE CONSISTENCY OF GEL, WAS CLEARLY FOREIGN AND WAS BLACK GREY WITH A SHINY SURFACE. IT WAS NOT POSSIBLE TO REMOVE THE MATERIAL VIA SUCTION. MULTIPLE ATTEMPTS WERE MADE WITH VARIOUS TOOLS TO REMOVE THE MATERIAL. IT WAS ONLY POSSIBLE TO REMOVE SMALL PARTS OF THE MATERIAL, BUT MORE THEN HALF OF THE MATERIAL REMAINED. THE RIGHT BRONCHIAL SYSTEM WAS AFTER REMOVAL OF THE MATERIAL COMPLETELY NORMAL. PATIENT REMAINED RESPIRATORY INSUFFICIENT. AFTER 2 HOURS (WITH MULTIPLE INTERRUPTIONS) THE PROCEDURE WAS DISCONTINUED. PATIENT DIED ON (B)(6) 2018. THERE WAS PERMISSION TO CONDUCT AN AUTOPSY. THE AUTOPSY REPORT WAS NOT YET FINAL.
1718912-2018-00005 IS ASSOCIATED WITH ARGUS CASE (B)(4), BIOTENE ORAL BALANCE GEL. INITIAL REPORT FILED UNDER MANUFACTURER NUMBER 1718912, THIS NUMBER HAS SINCE BEEN CHANGED TO 3012293198. ALL FOLLOW UP REPORTS WILL BE SUBMITTED UNDER THE CURRENT MANUFACTURER NUMBER OF 3012293198. THIS REPORT IS ASSOCIATED WITH ARGUS CASE (B)(4) BIOTENE ORAL BALANCE GEL. DEVICE EVALUATION (COMPLAINT NUMBER (B)(4)) ON 15 MAY 2018: BATCH REVIEW SHOWS NO DEVIATIONS OR QUALITY REMARKS. THE PRODUCT WAS PRODUCED ACCORDING TO THE SPECIFICATIONS. REVIEW OF ANALYTICAL TESTS SHOWS RESULTS CONFORM TO THE SPECIFICATIONS. THE PRODUCT IS NOT SUSPECTED TO HAVE BEEN CONTRIBUTORY TO THE CAUSE OF THE INCIDENT. CONCLUSION: NON-CONFIRMED. THE PRODUCT WAS PRODUCED ACCORDING TO THE SPECIFICATIONS. IT IS NOT SUSPECTED TO HAVE BEEN CONTRIBUTORY TO THE STATE OF HEALTH OF THE PATIENT.
CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF SUFFOCATION IN A PATIENT WHO RECEIVED GLYCERIN (BIOTENE ORAL BALANCE GEL) GEL FOR DRUG USE FOR UNKNOWN INDICATION. ON AN UNKNOWN DATE, THE PATIENT STARTED BIOTENE ORAL BALANCE GEL. ON (B)(6) 2018, AN UNKNOWN TIME AFTER STARTING BIOTENE ORAL BALANCE GEL, THE PATIENT EXPERIENCED SUFFOCATION (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT AND LIFE THREATENING). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FOREIGN BODY IN RESPIRATORY TRACT. BIOTENE ORAL BALANCE GEL WAS DISCONTINUED (DECHALLENGE WAS UNKNOWN). ON AN UNKNOWN DATE, THE OUTCOME OF THE SUFFOCATION WAS NOT REPORTED AND THE OUTCOME OF THE FOREIGN BODY IN RESPIRATORY TRACT WAS UNKNOWN. THE REPORTER CONSIDERED THE SUFFOCATION TO BE PROBABLY RELATED TO BIOTENE ORAL BALANCE GEL. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE FOREIGN BODY IN RESPIRATORY TRACT TO BE RELATED TO BIOTENE ORAL BALANCE GEL. THIS REPORT IS MADE BY GSK WITHOUT PREJUDICE AND DOES NOT IMPLY ANY ADMISSION OR LIABILITY FOR THE INCIDENT OR ITS CONSEQUENCES. ADDITIONAL DETAILS: THIS CASE WAS REPORTED BY A WHOLESALER EMPLOYEE, WHO RECEIVED THIS CASE FROM A HOSPITAL. ON (B)(6) 2018 THE PATIENT NEARLY SUFFOCATED DUE TO BIOTENE ORAL BALANCE GEL, THE GEL ENTERED THE LUNGS OF THE PATIENT. THE FOLLOWING BATCH NUMBERS WERE RETURNED TO THE WHOLESALER BY THE HOSPITAL: 101199, 5144526 (EXPIRY DATE: APR-2020), 5144966 (EXPIRY DATE: AUG-2020). FOLLOW UP WAS RECEIVED ON 29 MAR 2018: THIS CASE WAS REGARDING BATCH NUMBER 5144526, EXPIRY DATE APRIL 2020. THE REPORTER CONSIDERED THE SUFFOCATION TO BE RELATED TO BIOTENE ORAL BALANCE GEL. FOLLOW UP WAS RECEIVED ON 01 MAY 2018: THIS CASE WAS REPORTED BY A PHYSICIAN AND DESCRIBED THE OCCURRENCE OF DEATH IN A (B)(6)-YEAR-OLD MALE PATIENT WHO RECEIVED GLYCERIN (BIOTENE ORAL BALANCE GEL) GEL (BATCH NUMBER 5144526, EXPIRY DATE APRIL 2020) FOR DRY MOUTH. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED POLYMYALGIA RHEUMATICA (ADMITTED TO THE HOSPITAL ON (B)(6) 2018), NON ST SEGMENT ELEVATION MYOCARDIAL INFARCTION, UROSEPSIS, CHRONIC RENAL FAILURE WORSENED AND PERCUTANEOUS CORONARY INTERVENTION. CONCURRENT MEDICAL CONDITIONS INCLUDED DYSPHAGIA, LARYNGEAL DISCOMFORT AND FEEDING TUBE USER. ON (B)(6) 2018, THE PATIENT STARTED BIOTENE ORAL BALANCE GEL. ON (B)(6) 2018, 1 DAYS AFTER STARTING BIOTENE ORAL BALANCE GEL, THE PATIENT EXPERIENCED SUFFOCATION (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT, LIFE THREATENING AND OTHER: GSK MEDICALLY SIGNIFICANT). ON (B)(6) 2018, THE PATIENT EXPERIENCED DEATH (SERIOUS CRITERIA DEATH AND GSK MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ASPIRATION (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT) AND SPUTUM. ON AN UNKNOWN DATE, THE OUTCOME OF THE DEATH WAS FATAL AND THE OUTCOME OF THE SUFFOCATION WAS RECOVERED/RESOLVED AND THE OUTCOME OF THE ASPIRATION AND SPUTUM WERE UNKNOWN. THE PATIENT DIED ON (B)(6) 2018. THE REPORTED CAUSE OF DEATH WAS UNKNOWN CAUSE OF DEATH. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE DEATH, ASPIRATION AND SPUTUM TO BE RELATED TO BIOTENE ORAL BALANCE GEL. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2018 DUE POLYMYALGIA RHEUMATICA, NON-ST-ELEVATION-MYOCARDIAL INFARCTION (NSTEMI) FOR WHICH PERCUTANEOUS CORONARY INTERVENTION (PCI) OF THE RAMUS CIRCUMFLEX (RCX) (2017), SEPSIS DIFFERENTIAL DIAGNOSIS UROSEPSIS AND WORSENING WITH CHRONIC RENAL INSUFFICIENCY. PATIENT DID NOT RECEIVE ANYTHING ORALLY. AFTER PATIENT EXPERIENCED INCREASING DYSPNEA ON (B)(6) 2018, AND A SPUTUM PLUG WAS THOUGHT TO CAUSE THIS, THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT. THE LUNG WAS FLUSHED AND A SCOPY WAS DONE. BIOTENE ORAL BALANCE GEL WAS FOUND IN THE LUNG. THE PULMONOLOGIST COULD NOT REMOVE IT ALL DURING THE BRONCHOSCOPY. THEREFORE, THE PATIENT WAS TRANSFERRED TO AN ACADEMIC HOSPITAL, WHERE THE REMAINS OF THE BIOTENE ORAL BALANCE GEL WERE REMOVED. THE PATIENT WAS TRANSFERRED BACK TO THE ORIGINAL HOSPITAL THEREAFTER. IT WAS UNCLEAR WHETHER THE INCIDENT WITH THE BIOTENE ORAL BALANCE GEL (B)(6) 2018 CONTRIBUTED TO THE PATIENT'S DEATH. PATIENT DETAILS UPDATED. NO NEW MEDICALLY RELEVANT INFORMATION WAS RECEIVED ON 09 MAY 2018. FOLLOW UP INFORMATION RECEIVED FROM QUALITY ASSURANCE DEPARTMENT ON 15 MAY 2018: THIS CASE WAS ASSOCIATED WITH A PRODUCT COMPLAINT. QUALITY ASSURANCE ANALYSIS REVEALED THAT THE PRODUCT WAS NOT SUSPECTED TO HAVE BEEN CONTRIBUTED TO THE CAUSE OF THE INCIDENT. ALTERNATIVE CAUSES FOR THE EVENTS AND DEATH SHOULD BE CONSIDERED IN THE UNWELL PATIENT WITH A HISTORY OF SEPSIS AND MYOCARDIAL INFARCTION. THE PRODUCT WAS PRODUCED ACCORDING TO THE SPECIFICATIONS. IT WAS NOT SUSPECTED TO HAVE BEEN CONTRIBUTORY TO THE STATE OF HEALTH OF THE PATIENT. FOLLOW UP INFORMATION RECEIVED FROM THE PHYSICIAN ON 24 MAY 2018: THE REPORTER STATED THAT IN 2018 A ENT PHYSICIAN ANALYZED THE PATIENT DUE TO CHOKING, NO INDICATION FOR ENT-RELATED PROBLEMS INTERPRETED AS FUNCTIONAL. FURTHER INDICATION OF OSAS (OBSTRUCTIVE SLEEP APNEU SYNDROME). PATIENT STATED THAT HE HAD TROUBLE WITH SWALLOWING SINCE 2 WEEKS AND CHOKES QUICKLY/OFTEN. INCREASING DIFFICULTY SPEAKING, IT FELT LIKE A HOT POTATO WAS IN HIS THROAT. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2018 DUE TO POLYMYALGIA RHEUMATICA, NON ST ELEVATION MYOCARDIAL INFARCTION (NSTEMI) FOR WHICH PERCUTANEOUS CORONARY INTERVENTION (PCI) OF THE RAMUS CIRCUMFLEX (RCX) (2017), SEPSIS DIFFERENTIAL DIAGNOSIS UROSEPSIS AND WORSENING WITH CHRONIC RENAL INSUFFICIENCY. ALSO SEVERE DYSPHAGIA, BARELY LARYNGEAL RAISING AND FATIGUE. THEREFORE THE POLICY WAS TO NOT ADMINISTER ANYTHING ORALLY. THE PATIENT RECEIVED TUBE FEEDING VIA A STOMACH TUBE. SINCE (B)(6) 2018 THE PATIENT WAS INCREASINGLY CONFUSED/DELIRIC. AT (B)(6) 2018 THE PATIENT WAS TAKEN TO THE INTENSIVE CARE UNIT DUE TO RESPIRATORY INSUFFICIENCIES AND A BRONCHOSCOPY WAS PERFORMED. A CORPUS ALIENUM WAS DISCOVERED IN THE PATIENTS RIGHT LUNG. THE LUNG PHYSICIAN REPORTED INTRODUCTION VIA TUBE, GOOD VIEW, ENTIRE BRONCHIAL SYSTEM EASY TO SEE. RIGHT, IN THE STEM BRONCHUS A LARGE CLUMP BLACK GREY MATERIAL THAT CLOSED THE RIGHT LOWER LOBE AND THE RIGHT MIDDLE LOBE ENTIRELY. THE MATERIAL HAD THE CONSISTENCY OF GEL, WAS CLEARLY FOREIGN AND WAS BLACK GREY WITH A SHINY SURFACE. IT WAS NOT POSSIBLE TO REMOVE THE MATERIAL VIA SUCTION. MULTIPLE ATTEMPTS WERE MADE WITH VARIOUS TOOLS TO REMOVE THE MATERIAL. IT WAS ONLY POSSIBLE TO REMOVE SMALL PARTS OF THE MATERIAL, BUT MORE THEN HALF OF THE MATERIAL REMAINED. THE RIGHT BRONCHIAL SYSTEM WAS AFTER REMOVAL OF THE MATERIAL COMPLETELY NORMAL. PATIENT REMAINED RESPIRATORY INSUFFICIENT. AFTER 2 HOURS (WITH MULTIPLE INTERRUPTIONS) THE PROCEDURE WAS DISCONTINUED. PATIENT DIED AT (B)(6) 2018. THERE WAS PERMISSION TO CONDUCT AN AUTOPSY. THE AUTOPSY REPORT WAS NOT YET FINAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 401747 | BIOTENE ORAL BALANCE GEL | ORAL GEL | LFD | ULTRADENT PRODUCTS INC/ORATECH LLC | 5144526 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Death |