MAUDE Adverse Event Report: BLOCK DRUG CO., INC. CANDIDA DUO ACTIV TABS; DENTURE CLEANSER

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/28/2022

Event Type  Injury  

Event Description

Forgotten that it was the water with the denture cleaner and simply drank it [accidental device ingestion] stormy in the head [head discomfort] only ever dissolves half a tablet in half a glass of water [wrong technique in device usage process] case description: this case was reported by a consumer via call center representative(email) and described the occurrence of accidental device ingestion in a 87-year-old female patient who received denture cleanser (corega bio formula) tablet (batch number unk, expiry date unknown).For product used for unknown indication.On an unknown date, the patient started corega bio formula.On an unknown date, an unknown time after starting corega bio formula, the patient experienced accidental device ingestion (serious criteria gsk medically significant), head discomfort and wrong technique in device usage process.The action taken with corega bio formula was unknown.On an unknown date, the outcome of the accidental device ingestion, head discomfort and wrong technique in device usage process were unknown.It was unknown if the reporter considered the accidental device ingestion, head discomfort and wrong technique in device usage process to be related to corega bio formula.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details: adverse event information was received from consumer via call center representative(email) (b)(6) 2022.The consumer reported that "customer says she accidentally drank the water where she had her dentures in and is now asking whether it is toxic.She only ever dissolves half a tablet in half a glass of water.Customer says immediately after dissolving, the water is colored blue.After cleaning, she took out the dentures and left the water standing.When she saw half the glass of water today, clear and no longer blue, she had already forgotten that it was the water with the denture cleaner and simply drank it.Customer called us immediately.She says she's fine, she drank water afterwards.She is not feeling sick, but maybe a little stormy in the head.She is pi years old and sometimes does things like that because she has become forgetful.She asks if that's dangerous, but she would rather point out to us that the water should stay blue, then nobody drinks it.First and important question is it bad that the customer drank the water second, not very urgent question is it normal for the water to become transparent again after a while and couldn't that be changed so that the water used stays blue thank you for your comment today if possible.Kind regards." follow-up information was received from consumer via call center representative (email) on (b)(6) 2022.The reporter does not want to be contacted anymore.The consumer reported, "please do not send me any further email about this case.I had already explained a monday ago why this case was closed." case correction performed on the initially processed document received on (b)(6) 2022.Onset date of the events accidental device ingestion and head discomfort selected as (b)(6) 2022.Error correction received to the initially processed report received on (b)(6) 2022.Additional suspect added as candida duo activ tabs with formulation tablet, indication 'product used for unknown indication', action taken unknown dechallenge and rechallenge not applicable.

Manufacturer Narrative

Argus case id: (b)(4).

• Brand Name: CANDIDA DUO ACTIV TABS
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): BLOCK DRUG CO., INC.; memphis TN
• Manufacturer Contact: 184 liberty corner road; suite 200; warren, TN 07059 ; 8888255249
• MDR Report Key: 16814715
• MDR Text Key: 313999728
• Report Number: 1020379-2023-00015
• Device Sequence Number: 1
• Product Code: EFT
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/28/2022
• 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: 87 YR
• Patient Sex: Female