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

Device Problem Insufficient Information (3190)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/20/2018

Event Type  Injury  

Manufacturer Narrative

Mdr 1020379-2018-00048 is associated with argus case (b)(4) , polident daily care tablets.

Event Description

Accidental device ingestion.Accidentally swallowed a sip of polident daily care tablets solution.Instead of taking a glass of water (wrong technique in device usage process).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 daily care tablets) tablet for product used for unknown indication.On an unknown date, the patient started polident daily care tablets.On (b)(6) 2018, an unknown time after starting polident daily care tablets, the patient experienced accidental device ingestion (serious criteria gsk medically significant).On an unknown date, the patient experienced wrong technique in device usage process.The action taken with polident daily care tablets was unknown.On an unknown date, the outcome of the accidental device ingestion was not reported and the outcome of the wrong technique in device usage process was unknown.The reporter considered the accidental device ingestion to be related to polident daily care tablets.It was unknown if the reporter considered the wrong technique in device usage process to be related to polident daily care 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: consumer reported that 20 minutes ago she accidentally swallowed a sip of polident daily care tablets solution.Instead of taking a glass of water she took the glass with the solution.She called her pharmacy and they told her there was no danger at the moment as it was a small amount.

• Brand Name: POLIDENT DAILY CARE TABLETS
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): BLOCK DRUG CO., INC.; memphis TN
• Manufacturer Contact: po box 13398; research triangle park, NC 27709 ; 8888255249
• MDR Report Key: 7818468
• MDR Text Key: 118398111
• Report Number: 1020379-2018-00048
• 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: 08/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Date Manufacturer Received: 08/20/2018
• 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: 73 YR