MAUDE Adverse Event Report: BLOCK DRUG CO., INC. POLIDENT 3 MINUTE TABLETS; DENTURE CLEANSER

Device Problem Insufficient Information (3190)

Patient Problems Dementia (1808); Respiratory Distress (2045)

Event Date 10/14/2016

Event Type  Injury  

Manufacturer Narrative

This report is associated with argus case, (b)(4).Polident 3 minute tablets is marketed as polident tablets in the us.

Event Description

Respiratory distress.Probably chewed 3 effervescent tablets [accidental ingestion of product].Case description: this case was reported by a physician via other and described the occurrence of respiratory distress in a (b)(6) female patient who received double salt denture cleanser (polident 3 minute tablets) effervescent tablet for denture wearer.Concurrent medical conditions included dementia.In (b)(6) 2016, the patient started polident 3 minute tablets 3 dosage form(s) at an unknown frequency.In (b)(6) 2016, an unknown time after starting polident 3 minute tablets, the patient experienced respiratory distress (serious criteria gsk medically significant).On an unknown date, the patient experienced accidental ingestion of product.Polident 3 minute tablets was discontinued in (b)(6) 2016 (dechallenge was positive).On (b)(6) 2016, the outcome of the respiratory distress was recovered/resolved.On an unknown date, the outcome of the accidental ingestion of product was unknown.The reporter considered the respiratory distress to be related to polident 3 minute tablets.It was unknown if the reporter considered the accidental ingestion of product to be related to polident 3 minute tablets.Additional information: narrative received from (b)(6) loc.Medical conditions included dementia.The (b)(6) patient lived in a care home for dependent elderly people and was in a long-term care unit.In the night of (b)(6) 2016, the patient probably chewed 3 effervescent tablets of polident 3 minute cleanser (exposure to product).The box of tablets was found beside her during the night when the carers were doing their round.The carers counted the tablets that were missing (3).The patient was found in a state of respiratory distress (oxygen saturation was very low).The patient was transferred to a short-term unit as the decision was taken to perform the least invasive treatment (no patient emergency medical service called/no transfer to emergency unit) with symptomatic treatment including aspirations and oxygen.Intubation was not performed.The patient was closely monitored and within 2 days, her state improved.Treatment was stopped.On (b)(6) 2016, the patient was well (event reported to be resolved).

Manufacturer Narrative

1020379-2016-00058 is associated with argus case (b)(4), polident 3 minute tablets.Polident 3 minute tablets is marketed as polident tablets in the us.

Event Description

Respiratory distress [respiratory distress].Probably chewed 3 effervescent tablets [accidental device ingestion].Bronchial congestion [lower respiratory tract congestion].Case description: this case was reported by a physician via other and described the occurrence of respiratory distress in a (b)(6) -year-old female patient who received double salt denture cleanser (polident 3 minute tablets) effervescent tablet for denture wearer.Concurrent medical conditions included dementia.In (b)(6) 2016, the patient started polident 3 minute tablets 3 dosage form(s) at an unknown frequency.In (b)(6) 2016, an unknown time after starting polident 3 minute tablets, the patient experienced respiratory distress (serious criteria gsk medically significant).On an unknown date, the patient experienced accidental ingestion of product.Polident 3 minute tablets was discontinued in (b)(6) 2016 (dechallenge was positive).On (b)(6) 2016, the outcome of the respiratory distress was recovered/resolved.On an unknown date, the outcome of the accidental ingestion of product was unknown.The reporter considered the respiratory distress to be related to polident 3 minute tablets.It was unknown if the reporter considered the accidental ingestion of product to be related to polident 3 minute tablets.Additional information narrative received from (b)(6) loc: medical conditions included dementia.The (b)(6) year-old patient lived in a care home for dependent elderly people and was in a long-term care unit.In the night of (b)(6) 2016, the patient probably chewed 3 effervescent tablets of polident 3 minute cleanser (exposure to product).The box of tablets was found beside her during the night when the carers were doing their round.The carers counted the tablets that were missing (3).The patient was found in a state of respiratory distress (oxygen saturation was very low).The patient was transferred to a short-term unit as the decision was taken to perform the least invasive treatment (no patient emergency medical service called/no transfer to emergency unit) with symptomatic treatment including aspirations and oxygen.Intubation was not performed.The patient was closely monitored and within 2 days, her state improved.Treatment was stopped.On (b)(6) 2016, the patient was well (event reported to be resolved).Follow-up information received on 17 november 2016: on (b)(6) 2016, an unknown time after starting polident 3 minute tablets, the patient experienced respiratory distress (serious criteria gsk medically significant, life threatening and other: gsk medically significant) and lower respiratory tract congestion.On an unknown date, the patient experienced accidental device ingestion (serious criteria gsk medically significant).The patient was treated with amoxicillin trihydrate, potassium clavulanate (augmentin).On (b)(6) 2016, the outcome of the respiratory distress and lower respiratory tract congestion were recovered/resolved.On an unknown date, the outcome of the accidental device ingestion was unknown.The reporter considered the respiratory distress and lower respiratory tract congestion to be related to polident 3 minute tablets.It was unknown if the reporter considered the accidental device ingestion to be related to polident 3 minute tablets.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.It was reported that ten sachets of polident were opened and 3 tables were missing.The patient was very congested and oxygen saturation was 63 %.The patient was transferred to a short-term unit given her age and her pathology.As treatment, a bronchial aspiration was performed and the patient was placed under oxygen therapy.Augmentin was also given to the patient.Bronchial aspirations and oxygen therapy were performed for 48 hours.The outcome was favorable.The physician specified that the effervescent tablets had probably melted in the patient's throat.He added that the patient had no respiratory problems before.The exposure was reported to be due to the patient's dementia.

• Brand Name: POLIDENT 3 MINUTE TABLETS
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): BLOCK DRUG CO., INC.; 2149 harbor avenue; memphis TN 38113
• Manufacturer (Section G): GSK
• Manufacturer Contact: po box 13398; research triangle park, NC 27709 ; 8888255249
• MDR Report Key: 6078548
• MDR Text Key: 59189682
• Report Number: 1020379-2016-00058
• 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,health professional
• Type of Report: Initial,Followup
• Report Date: 10/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Initial Date Manufacturer Received: 10/21/2016
• Initial Date FDA Received: 11/04/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 94 YR