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

Device Problem Insufficient Information (3190)

Patient Problem Chemical Exposure (2570)

Event Type  Injury  

Manufacturer Narrative

Report 1020379-2017-00061 is associated with argus case (b)(4), polident overnight denture cleanser tablets.

Event Description

I was soaking my dentures overnight and accidental drunk some of the solution [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 double salt denture cleanser (polident overnight denture cleanser tablets) tablet (batch number unk, expiry date unknown) for product used for unknown indication.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) and accidental ingestion of drug.On an unknown date, the outcome of the accidental device ingestion and accidental ingestion of drug were 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 on (b)(6) 2017.Consumer reported that, "i was soaking my dentures overnight and accidental drunk some of the solution".

Manufacturer Narrative

1020379-2017-00061 is associated with argus case (b)(4), polident overnight denture cleanser tablets.

Event Description

Case description: this case was reported by a consumer and described the occurrence of accidental device ingestion in a female patient who received double salt denture cleanser (polident overnight denture cleanser tablets) tablet (batch number unk, expiry date unknown) for product used for unknown indication.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) and accidental ingestion of drug.On an unknown date, the outcome of the accidental device ingestion and accidental ingestion of drug were 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 on (b)(6) 2017.Consumer reported that, "i was soaking my dentures overnight and accidental drunk some of the solution".Follow up information was received on (b)(6) 2017.The consumer stated, "i did a dumb thing.I accidentally placed my polident solution near my water glass and i drank a big gulp of it before i realized.I drank a large glass of water after doing so as instructed.I did not have any side effects." the consumer denied having to see a doctor for this complaint and denied consent to follow up with her.

• Brand Name: POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): BLOCK DRUG CO., INC.; 2149 harbor avenue; memphis TN 38113
• Manufacturer (Section G): GSK
• Manufacturer Contact: po box 13398; research triangle park, NC 27709 ; 8888255249
• MDR Report Key: 6767412
• MDR Text Key: 81832500
• Report Number: 1020379-2017-00061
• 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: 07/28/2017

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: 07/28/2017
• Initial Date FDA Received: 08/04/2017
• Supplement Dates Manufacturer Received: 08/08/2017
• Supplement Dates FDA Received: 08/15/2017
• 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