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

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

Patient Problem Sore Throat (2396)

Event Date 05/31/2021

Event Type  Injury  

Manufacturer Narrative

Argus case (b)(4).

Event Description

Accidentally swallowed one tablet of polident denture cleanser [accidental device ingestion] throat is pain/sore throat [sore throat] case description: this case was reported by a consumer via call center representative and described the occurrence of accidental device ingestion in a patient who received denture cleanser (polident denture cleanser) tablet (batch number unk, expiry date unknown) for product used for unknown indication.On an unknown date, the patient started polident denture cleanser.On (b)(6) 2021, 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 sore throat.The action taken with polident denture cleanser was unknown.On an unknown date, the outcome of the accidental device ingestion and sore throat were unknown.It was unknown if the reporter considered the accidental device ingestion and sore throat to be related to polident denture cleanser.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional information: adverse event details received by a consumer via call center representative on (b)(6)2021, consumer stated that "last night, family member accidentally swallowed one tablet of polident denture cleanser tablet, what will happen.I asked family member whether there is any discomfort, family member said throat is pain/sore throat, then i asked family member to drink more water".

• Brand Name: POLIDENT DENTURE CLEANSER
• 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: 12021022
• MDR Text Key: 260215648
• Report Number: 1020379-2021-00030
• 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: 06/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2021
• 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: 06/01/2021
• 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