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

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

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Argus case (b)(4).

Event Description

I accidentally put some of the solution in the mouth.I may have swallowed some [accidental device ingestion].Case description: this case was reported by a consumer and described the occurrence of accidental device ingestion in a female patient who received denture cleanser (polident denture cleanser tablets) tablet (batch number unk, expiry date unknown) for dental cleaning.On an unknown date, the patient started polident denture cleanser tablets.On an unknown date, an unknown time after starting polident denture cleanser tablets, the patient experienced accidental device ingestion (serious criteria gsk medically significant).On an unknown date, the outcome of the accidental device ingestion was unknown.It was unknown if the reporter considered the accidental device ingestion to be related to polident denture cleanser 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: adverse event information was received via call on 14 october 2019.The consumer reported that "i was soaking my teeth overnight with polident.I accidentally put some of the solution in the mouth.I may have swallowed some.I am not sure.What should i do? if you do not know what to do then i have to go.Should i contact the doctor? i am going to do that now".

• Brand Name: POLIDENT DENTURE CLEANSER 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: 9260112
• MDR Text Key: 169740457
• Report Number: 1020379-2019-00052
• Device Sequence Number: 1
• Product Code: EFT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/14/2019

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: 10/14/2019
• Initial Date FDA Received: 10/31/2019
• 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