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

Lot Number 17E15ORG C

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 11/23/2020

Event Type  Injury  

Manufacturer Narrative

Argus case (b)(4).

Event Description

Accidentally drunk the denture cleanser [accidental device ingestion] expired product used [expired device used].Case description: this case was reported by a consumer via call center representative and described the occurrence of accidental device ingestion in a (b)(6) female patient who received denture cleanser (polident 3 minute tablets) tablet (batch number 17e15org c, expiry date 30th april 2020) for dental care.On (b)(6) 2020, the patient started polident 3 minute tablets at an unknown dose and frequency.On (b)(6) 2020, an unknown time after starting polident 3 minute tablets, the patient experienced accidental device ingestion (serious criteria gsk medically significant).On an unknown date, the patient experienced expired device used.Polident 3 minute tablets was discontinued on (b)(6) 2020 (dechallenge was unknown).On (b)(6) 2020, the outcome of the accidental device ingestion was recovered/resolved.On an unknown date, the outcome of the expired device used was unknown.It was unknown if the reporter considered the accidental device ingestion and expired device used 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.Additional details: the initial and follow up information dated 23 nov 2020 and 24 nov 2020 were processed together.The consumer called because she accidentally drunk the denture cleanser polident 3 minute.She asked whether she should be concerned.Followup information received on 24 nov 2020.The batch number and expiry date of product was updated.

• Brand Name: POLIDENT 3 MINUTE TABLETS
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): BLOCK DRUG CO., INC.; memphis; TN
• Manufacturer Contact: po box 13398; research triangle park; 8888255249
• MDR Report Key: 10951264
• MDR Text Key: 219963470
• Report Number: 1020379-2020-00061
• Device Sequence Number: 1
• Product Code: EFT
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 04/30/2020
• Device Lot Number: 17E15ORG C
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/23/2020
• 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: 43 YR