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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Nausea (1970); Discomfort (2330)

Event Date 04/21/2016

Event Type  Injury  

Manufacturer Narrative

This report is associated with argus case (b)(4), polident denture cleanser.

Event Description

Device ingestion [accidental device ingestion].Feel like vomiting [nausea].Throat was uncomfortable [pharynx discomfort].Misuse [wrong technique in device usage process].Chest discomfort.Case description: this case was reported by a consumer via call center representative and described the occurrence of wrong technique in device usage process in a (b)(6) female patient who received double salt denture cleanser (polident denture cleanser) tablet for product used for unknown indication.On (b)(6) 2016, the patient started polident denture cleanser.On (b)(6) 2016 23:00, the patient experienced wrong technique in device usage process and nausea.On an unknown date, the patient experienced pharynx discomfort.On an unknown date, the outcome of the wrong technique in device usage process, nausea and pharynx discomfort were unknown.The reporter considered the nausea to be possibly related to polident denture cleanser.It was unknown if the reporter considered the pharynx discomfort to be related to polident denture cleanser.Additional details: the consumer was an (b)(6) female.Her servant dissolved polident denture cleanser into half bowl of water and she drank it last night ((b)(6) 2016 23.00).Polident denture cleanser was mistakenly used as foaming tablet.After drinking it, the consumer felt like vomiting and her throat was uncomfortable.Her daughter called to inquire if any allergy reaction would happen to her mother.Follow up information was received from consumer on 22 apr 2016: on (b)(6) 2016, an unknown time after starting polident denture cleanser, the patient experienced accidental device ingestion (serious criteria gsk medically significant).On an unknown date, the patient experienced chest discomfort.On an unknown date, the outcome of the chest discomfort was not recovered/not resolved (the patient's daughter reported that the patient still felt chest discomfort).It was reported that after taking a gastrointestinal drug, the patient felt no discomfort in her stomach and intestine.

• Brand Name: POLIDENT DENTURE CLEANSER
• 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: 5999576
• MDR Text Key: 56457931
• Report Number: 1020379-2016-00044
• 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: consumer,foreign
• Type of Report: Initial
• Report Date: 04/22/2016

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: Lay User/Patient
• Initial Date Manufacturer Received: 04/22/2016
• Initial Date FDA Received: 10/05/2016
• 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): Other
• Patient Age: 85 YR