MAUDE Adverse Event Report: BLOCK DRUG CO., INC. JAPANESE 5 MINUTE POLIDENT (ENZYME WITH SODIUM PERCARBONATE)-MFC51009; DENTURE CLEANSER

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Aspiration/Inhalation (1725); Hypoxia (1918); Pneumonia (2011); Swelling (2091); Foreign Body In Patient (2687)

Event Date 09/12/2018

Event Type  Injury  

Manufacturer Narrative

Mfr 1020379-2018-00056 is associated with argus case (b)(4), japanese 5 minute polident (enzyme with sodium percarbonate).Japanese 5 minute polident (enzyme with sodium percarbonate) is marketed as polident in the us.

Event Description

Pneumonia aspiration [pneumonia aspiration], foreign body aspiration [foreign body aspiration], hypoxia [hypoxia], foreign body in respiratory tract [foreign body in trachea], oedema mucosal [mucosal swelling].Case description: this case was reported by a non-health professional via other manufacturer and described the occurrence of pneumonia aspiration in a (b)(6) male patient who received denture cleanser (japanese 5 minute polident (enzyme with sodium percarbonate)-mfc51009) tablet for an unknown indication.Concurrent medical conditions included dementia and hospitalisation.On an unknown date, the patient started japanese 5 minute polident (enzyme with sodium percarbonate)-mfc51009.On (b)(6) 2018 18:30, the patient experienced foreign body aspiration (serious criteria gsk medically significant) and accidental ingestion of product.On (b)(6) 2018, less than a day after starting japanese 5 minute polident (enzyme with sodium percarbonate)-mfc51009, the patient experienced pneumonia aspiration (serious criteria gsk medically significant), hypoxia (serious criteria gsk medically significant), foreign body in trachea and mucosal swelling.On an unknown date, the outcome of the pneumonia aspiration, foreign body aspiration, hypoxia, foreign body in trachea, mucosal swelling and accidental ingestion of product were unknown.It was unknown if the reporter considered the pneumonia aspiration, foreign body aspiration, hypoxia, foreign body in trachea and mucosal swelling to be related to japanese 5 minute polident (enzyme with sodium percarbonate)-mfc51009.Additional details: on (b)(6) 2018, at 18:30, the patient with dementia ingested four tablets of japanese 5 minute polident (enzyme with sodium percarbonate)-mfc51009, and aspiration was noted with some of the pieces.Whether the patient was given first-aid or not was unknown.He was examined by a physician on the same day.It was not choking of the pieces, but bronchoscopy revealed that some of the pieces melt and were foaming in the trachea.Decreased oxygenation and tracheal mucosal swelling was noted.Treatment: none.

Event Description

Pneumonia aspiration.Foreign body aspiration.Hypoxia.Respiratory failure.Foreign body in respiratory tract [foreign body in trachea].Oedema mucosal [mucosal swelling].Dyspnoea [shortness of breath].Cough.Laryngitis.Dysphonia [hoarseness].Tracheal erythema.Pharyngeal oedema [throat swelling].Case description: this case was reported by a non-health professional via other manufacturer and described the occurrence of pneumonia aspiration in a 94-year-old male patient who received denture cleanser (japanese 5 minute polident (enzyme with sodium percarbonate)-mfc51009) tablet for an unknown indication.Concurrent medical conditions included dementia and hospitalisation.On an unknown date, the patient started japanese 5 minute polident (enzyme with sodium percarbonate)-mfc51009.On (b)(6) 2018 18:30, the patient experienced foreign body aspiration (serious criteria gsk medically significant) and accidental ingestion of product.On (b)(6) 2018, less than a day after starting japanese 5 minute polident (enzyme with sodium percarbonate)-mfc51009, the patient experienced pneumonia aspiration (serious criteria gsk medically significant), hypoxia (serious criteria gsk medically significant), foreign body in trachea and mucosal swelling.On an unknown date, the outcome of the pneumonia aspiration, foreign body aspiration, hypoxia, foreign body in trachea, mucosal swelling and accidental ingestion of product were unknown.It was unknown if the reporter considered the pneumonia aspiration, foreign body aspiration, hypoxia, foreign body in trachea and mucosal swelling to be related to japanese 5 minute polident (enzyme with sodium percarbonate)-mfc51009.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details on (b)(6) 2018, at 18:30, the patient with dementia ingested four tablets of japanese 5 minute polident (enzyme with sodium percarbonate)-mfc51009, and aspiration was noted with some of the pieces.Whether the patient was given first-aid or not was unknown.He was examined by a physician on the same day.It was not choking of the pieces, but bronchoscopy revealed that some of the pieces melt and were foaming in the trachea.Decreased oxygenation and tracheal mucosal swelling was noted.Treatment: none no further information is expected.Follow-up information received from japan poison information center on 08 february 2019 additional events included shortness of breath (non-serious), cough (non-serious), respiratory failure (serious criteria gsk medically significant), laryngitis (non-serious), hoarseness (non-serious), tracheal erythema (non-serious), throat swelling (non-serious), and wrong product selected (non-serious).Following dinner of (b)(6) 2018, at 18:30, the patient accidentally ingested the denture cleanser, mistaking it for food.Difficulty in breathing, cough, respiratory failure, laryngitis, and hoarseness were noted.The bronchoscopy confirmed foamy substance adhering to the intratracheal and intrabronchial areas, redness of the tracheal wall, and swollen epiglottis.As treatments, oxygenation, tracheal intubation, and a few days of ventilation were performed.As of (b)(6) 2019, the pneumonia aspiration, foreign body aspiration, hypoxia, respiratory failure, foreign body in trachea, mucosal swelling, shortness of breath, cough, laryngitis, hoarseness, tracheal erythema, and throat swelling were resolved.As of the time of this report, the outcome of wrong product selected was unknown.The duration of the hospitalization was unknown.It was unknown if the reporter considered the respiratory failure, foreign body in trachea, shortness of breath, cough, laryngitis, hoarseness, tracheal erythema, and throat swelling to be related to japanese 5 minute polident (enzyme with sodium percarbonate)-mfc51009.

Manufacturer Narrative

Initial report is associated with argus case (b)(4), japanese 5 minute polident (enzyme with sodium percarbonate).Japanese 5 minute polident (enzyme with sodium percarbonate) is marketed as polident in the us.

• Brand Name: JAPANESE 5 MINUTE POLIDENT (ENZYME WITH SODIUM PERCARBONATE)-MFC51009
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): BLOCK DRUG CO., INC.; memphis TN
• MDR Report Key: 7902434
• MDR Text Key: 121567643
• Report Number: 1020379-2018-00056
• Device Sequence Number: 1
• Product Code: EFT
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 09/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Date Manufacturer Received: 02/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 94 YR
• Patient Weight: 49