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

Lot Number UNKNOWN

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Chemical Exposure (2570)

Event Type  Injury  

Manufacturer Narrative

This report is associated with (b)(4), polident overnight denture cleanser tablets.

Event Description

I swallowed a little amount of it [accidental device ingestion].Case description: this case was reported by a consumer and described the occurrence of accidental device ingestion in a (b)(6) female patient who received denture cleanser (polident overnight denture cleanser tablets) tablet (batch number unknown, expiry date unknown) for denture wearer.On an unknown date, the patient started polident overnight denture cleanser tablets.On an unknown date, an unknown time after starting polident overnight 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 overnight denture cleanser tablets.Additional information, adverse event information was received via call on 25 june 2018.Consumer reported that, "i swallowed a little amount of it and drank a lot of water.I thought it was my coco." follow up information was received on 26 june 2018.Consumer provided additional information related to age.Consumer was doing well and not felt anything after accidentally swallowing the product.Consumer intend to see her doctor by next month ((b)(6) 2018) before her doctor leaves.Consumer agreed for safety team to contact her doctor and send her the authorization form.Consumer was using polident from past 2.5 years now.Consumer was still using it to clean her dentures.Initial and follow-up information was included in the above narrative.

Manufacturer Narrative

Initial report is associated with argus case (b)(4), polident overnight denture cleanser tablets.

Event Description

I swallowed a little amount of it [accidental device ingestion].She was not feeling well at the moment [feeling unwell].Case description: this case was reported by a consumer and described the occurrence of accidental device ingestion in a 86-year-old female patient who received denture cleanser (polident overnight denture cleanser tablets) tablet (batch number unknown, expiry date unknown) for denture wearer.On an unknown date, the patient started polident overnight denture cleanser tablets.On an unknown date, an unknown time after starting polident overnight 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 overnight 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 information, adverse event information was received via call on (b)(6) 2018.Consumer reported that, "i swallowed a little amount of it and drank a lot of water.I thought it was my coco." follow up information was received on 26 june 2018.Consumer provided additional information related to age.Consumer was doing well and not felt anything after accidentally swallowing the product.Consumer intend to see her doctor by next month ((b)(6) 2018) before her doctor leaves.Consumer agreed for safety team to contact her doctor and send her the authorization form.Consumer was using polident from past 2.5 years now.Consumer was still using it to clean her dentures.Initial and follow-up information was included in the above narrative.Follow up information was received on 09 july 2018.Consumer reported that, "she is doing well and will see her doctor tomorrow but not regarding her accidental ingestion of polident overnight." consumer provided her age but unable to provide any information as consumer was not feeling well at the movement.Consumer agreed to be given callback for further details on ae event.As consumer was not feeling well "feeling unwell" event was updated in the case with outcome of event not recovered.It was unknown if the reporter considered the malaise to be related to polident overnight denture cleanser tablets.

• Brand Name: POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): BLOCK DRUG CO., INC.; memphis TN
• MDR Report Key: 7659227
• MDR Text Key: 113064544
• Report Number: 1020379-2018-00033
• 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
• Type of Report: Initial,Followup
• Report Date: 06/25/2018

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 Lot Number: UNKNOWN
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/25/2018
• Initial Date FDA Received: 07/03/2018
• Supplement Dates Manufacturer Received: 07/09/2018
• Supplement Dates FDA Received: 07/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 86 YR