MAUDE Adverse Event Report: BLOCK DRUG CO., INC. POLIDENT DENTURE CLEANSER (UNKNOWN)

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Vomiting (2144)

Event Date 09/22/2020

Event Type  Injury  

Manufacturer Narrative

Argus case (b)(4).

Event Description

Vomiting [vomiting], hypotension [hypotension], cardiac failure [cardiac failure aggravated], anaemia [anaemia aggravated], physical deconditioning [physical deconditioning], pallor [complexion ill].Case description: this case was reported by a nurse via sales rep and described the occurrence of vomiting in a (b)(6) patient who received denture cleanser (polident denture cleanser (unknown)) tablet for denture wearer.Concurrent medical conditions included denture wearer.On an unknown date, the patient started polident denture cleanser (unknown) (oral) at an unknown dose and frequency.On (b)(6) 2020, less than a day after starting polident denture cleanser (unknown), the patient experienced vomiting (serious criteria hospitalization) and accidental ingestion of product.The action taken with polident denture cleanser (unknown) was unknown.On an unknown date, the outcome of the vomiting and accidental ingestion of product were unknown.It was unknown if the reporter considered the vomiting to be related to polident denture cleanser (unknown).[clinical course] on (b)(6) 2020, the patient experienced vomiting due to accidental ingestion (serious criteria hospitalization).The patient swallowed a large amount of polident denture cleanser and was emergently taken to the hospital.The inside of the patient's mouth was blue and 5 or 6 tablets were seen in the mouth, which were taken out.The polident denture cleanser was likely to have already been discarded by a caregiver and it was unknown how many tablets the patient had taken.The patient had a medical history.He/she was being hospitalized and followed up.It was said that the possible impact could occur today or tomorrow.The patient's details were ongoing.Follow-up information received from the reporting non-health professional on 8 october 2020 [clinical course]: the patient was a (b)(6) male.The suspect product was polident denture cleanser (unknown) tablet for denture wearer.Concomitant products included furosemide (furosemide tablets), tolvaptan (samsca tablets), spironolactone (spironolactone tablets), acetylsalicylic acid (bayaspirin tablets), febuxostat (feburic tablets), lansoprazole (lansoprazole-od tablets), atorvastatin calcium (atorvastatin calcium tablet), eldecalcitol (edirol capsule), epinastine hydrochloride (epinastine hydrochloride tablets), ferrous sodium citrate (ferrous citrate na tablet), miyari bacteria (miya-bm tablets) and pimobendan (pimobendan tablet).Concurrent medical conditions included denture wearer, cardiac failure congestive, angina pectoris, hypertension, renal failure chronic, dementia, living in care (level of care: 2) and anaemia.On (b)(6) 2020, less than a day after starting polident denture cleanser (unknown), the patient experienced vomiting due to accidental ingestion (serious criteria hospitalization), hypotension (serious criteria hospitalization), cardiac failure aggravated (serious criteria hospitalization and gsk medically significant), anaemia aggravated (serious criteria hospitalization), physical deconditioning (serious criteria hospitalization) and complexion ill (serious criteria non-serious).The adverse event of this case was poor health condition not due to treatment with drugs but due to accidental ingestion.The patient vomitted due to accidental ingestion of polident denture cleanser and was emergently taken to the hospital, followed by hospitalization for examinations.During 5-7 am of the same day, it seemed the patient had taken a large dose at his own room of an living institution with services for the elderly.Since the scene was not secured, the amount of the accidental ingestion was unknown.At 7 am, 5 or 6 tablets left in the patient's mouth was removed by the fingers of a caregiver.At 7:30 am, the patient vomitted a large amount of blue liquid.His vital signs were as follows: blood pressure, 105/60 per min; oxygen saturation (sat), 96%; body temperature 36.8 degrees celsius).Subsequently, the patient vomited again his consciousness was clear.He answered questions as "i'm all right".At 8:05 am, his blood pressure was 80/50, sat 99%, pulse (p) 110/min, bt 35.0 degrees celsius, and he looked pale.An ambulance was called.Background of the accidental ingestion: the patient took a large amount of polident kept at the lavatory of his own room of a living institution with services for the elderly.He was found by a caregiver and taken by an ambulance.The polident was usually used by the caregiver to clean the patient's dentures.On an unknown date, the outcomes of the hypotension, cardiac failure aggravated and anaemia aggravated were recovered/resolved and the outcomes of the physical deconditioning and complexion ill were unknown.Results of relevant diagnostic test results ((b)(6) 2020, 07[?]30 am) blood pressure, temperature, sat.((b)(6) 2020, 08[?]05 am) blood pressure: 80/50, sat: 99%, pulse 110/min, temperature: 35.0 degrees celsius, complexion ill.[reporter's comment]: it was unknown if the reporter considered the vomiting due to accidental ingestion, hypotension, cardiac failure aggravated, anaemia aggravated, physical deconditioning to be related to polident denture cleanser (unknown).

Manufacturer Narrative

Argus case (b)(4).

Event Description

Gastritis erosive [gastric erosions], vomiting [vomiting], hypotension [hypotension], cardiac failure [cardiac failure aggravated], anaemia [anaemia aggravated], physical deconditioning [physical deconditioning], pallor [complexion ill], decreased appetite [inappetence], arrhythmia [arrhythmia].Case description: this case was reported by a nurse via sales rep and described the occurrence of gastric erosions in a 90-year-old male patient who received denture cleanser (polident denture cleanser (unknown)) tablet for denture wearer.Concurrent medical conditions included denture wearer, cardiac failure congestive, angina pectoris, hypertension, renal failure chronic, dementia, living in care and anaemia.Concomitant products included furosemide (furosemide tablets), tolvaptan (samsca tablets), spironolactone (spironolactone tablets), acetylsalicylic acid (bayaspirin tablets), febuxostat (feburic tablets), lansoprazole (lansoprazole-od tablets), atorvastatin calcium (atorvastatin calcium tablet), eldecalcitol (edirol capsule), epinastine hydrochloride (epinastine hydrochloride tablets), ferrous sodium citrate (ferrous citrate na tablet), miyari bacteria (miya-bm tablets) and pimobendan (pimobendan tablet).On (b)(6) 2020, the patient started polident denture cleanser (unknown) (oral) at an unknown dose and frequency.On (b)(6) 2020, less than a day after starting polident denture cleanser (unknown), the patient experienced vomiting (serious criteria hospitalization), hypotension (serious criteria hospitalization), cardiac failure aggravated (serious criteria hospitalization and gsk medically significant), anaemia aggravated (serious criteria hospitalization), physical deconditioning, complexion ill and accidental ingestion of product.On an unknown date, the patient experienced gastric erosions (serious criteria gsk medically significant), inappetence and arrhythmia (serious criteria gsk medically significant).The action taken with polident denture cleanser (unknown) was unknown.On (b)(6) 2020, the outcome of the physical deconditioning and complexion ill were recovered/resolved.On an unknown date, the outcome of the gastric erosions, inappetence, arrhythmia and accidental ingestion of product were unknown and the outcome of the vomiting, hypotension, cardiac failure aggravated and anaemia aggravated were recovering/resolving.The reporter considered the gastric erosions and inappetence to be related to polident denture cleanser (unknown).It was unknown if the reporter considered the vomiting, hypotension, cardiac failure aggravated, anaemia aggravated, physical deconditioning, complexion ill and arrhythmia to be related to polident denture cleanser (unknown).[reporter's comment]: it was unknown if the reporter considered the inappetence and arrhythmia to be related to polident denture cleanser (unknown).The reporter considered the gastric erosions to be related to polident denture cleanser (unknown).The gastric erosions were caused by polident denture cleanser (unknown).Follow-up information received from the reporting non-health professional on 29 october 2020.[clinical course]: on (b)(6) 2020, the patient experienced inappetence (seriousness: non-serious) in the state of gastric erosions (serious criteria gsk medically significant) by polident denture cleanser (unknown) and arrhythmia (serious criteria gsk medically significant) (affected by concurrent cardiac failure) during hospitalization.On (b)(6) 2020, the outcome of the inappetence, gastric erosions and arrhythmia were recovered/resolved.

• Brand Name: POLIDENT DENTURE CLEANSER (UNKNOWN)
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): BLOCK DRUG CO., INC.; memphis TN
• MDR Report Key: 10706016
• MDR Text Key: 216616434
• Report Number: 1020379-2020-00051
• Device Sequence Number: 1
• Product Code: EFT
• Combination Product (y/n): Y
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 1) FUROSEMIDE TABLETS; 10) FERROUS CITRATE NA TABLET; 11)MIYA-BM TABLETS; 12) PIMOBENDAN TABLET; 2) SAMSCA TABLETS; 3) SPIRONOLACTONE TABLETS; 4) BAYASPIRIN TABLETS; 5) FEBURIC TABLETS; 6) LANSOPRAZOLE-OD TABLETS; 7) ATORVASTATIN CALCIUM TABLET; 8) EDIROL CAPSULE; 9) EPINASTINE HYDROCHLORIDE TABLETS
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 90 YR