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

Lot Number 17A027RGC

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

Patient Problem Irritation (1941)

Event Date 07/18/2018

Event Type  Injury  

Manufacturer Narrative

This is associated with argus case (b)(4), polident 3 minute.

Event Description

I swallowed a mouthful of water containing a tablet of polident 3 minute last night; [accidental device ingestion].He felt irritation in his stomach; [gastric irritation].Case description: this case was reported by a consumer and described the occurrence of accidental device ingestion in a (b)(6) male patient who received denture cleanser (polident 3 minute) tablet (batch number 17a027rgc, expiry date 31st december 2019) for denture wearer.On (b)(6) 2018, the patient started polident 3 minute.On (b)(6) 2018, an unknown time after starting polident 3 minute, the patient experienced accidental device ingestion (serious criteria gsk medically significant) and gastric irritation.Polident 3 minute was discontinued on (b)(6) 2018 (dechallenge was negative).On an unknown date, the outcome of the accidental device ingestion was unknown and the outcome of the gastric irritation was not recovered/not resolved.It was unknown if the reporter considered the accidental device ingestion and gastric irritation to be related to polident 3 minute.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 information was received via phone call on 19 july 2018.Consumer reported, "i swallowed about a mouth full of water with polident.I have irritation in my stomach right away.I called poison control.Will my irritation continue." today, he still feels the irritation in his stomach.

• Brand Name: POLIDENT 3 MINUTE
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): BLOCK DRUG CO, INC.; memphis TN
• Manufacturer Contact: po box 13398; research triangle park, NC 27709
• MDR Report Key: 7723808
• MDR Text Key: 115189281
• Report Number: 1020379-2018-00040
• 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: 07/19/2018

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
• Device Expiration Date: 12/31/2019
• Device Lot Number: 17A027RGC
• Initial Date Manufacturer Received: 07/19/2018
• Initial Date FDA Received: 07/26/2018
• 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: 79 YR