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

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

Patient Problem Itching Sensation (1943)

Event Type  Injury  

Manufacturer Narrative

1020379-2018-00006 is associated with argus case (b)(4), polident 3 minutes.

Event Description

Accidentally drank some of the solution.[accidental device ingestion].Is very itchy now [pruritus].Case description: this case was reported by a consumer and described the occurrence of accidental device ingestion in a male patient who received double salt denture cleanser (polident 3 minute) tablet (batch number unk, expiry date unknown) for product used for unknown indication.On an unknown date, the patient started polident 3 minute.On an unknown date, an unknown time after starting polident 3 minute, the patient experienced accidental device ingestion (serious criteria gsk medically significant) and itchy.The action taken with polident 3 minute was unknown.On an unknown date, the outcome of the accidental device ingestion and itchy were unknown.It was unknown if the reporter considered the accidental device ingestion and itchy to be related to polident 3 minute.Additional details, adverse event information was received on 17 january 2018.Consumer called in regarding polident 3-minute, he accidentally drank some of the solution.Consumer stated was very itchy now.Consumer wanted to know what to do.

Event Description

Accidentally drank some of the solution.[accidental device ingestion].Is very itchy now [pruritus].Have had some rashes in different places.[rash].Case description: this case was reported by a consumer and described the occurrence of accidental device ingestion in a male patient who received double salt denture cleanser (polident 3 minute) tablet (batch number unk, expiry date unknown) for product used for unknown indication.On an unknown date, the patient started polident 3 minute.On an unknown date, an unknown time after starting polident 3 minute, the patient experienced accidental device ingestion (serious criteria gsk medically significant) and itchy.The action taken with polident 3 minute was unknown.On an unknown date, the outcome of the accidental device ingestion and itchy were unknown.It was unknown if the reporter considered the accidental device ingestion and itchy 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 details, adverse event information was received on 17 january 2018.Consumer called in regarding polident 3-minute, he accidentally drank some of the solution.Consumer stated was very itchy now.Consumer wanted to know what to do.Follow up information was received on 23 january 2018.Consumer reported that he had some rashes in different places.He was ok.He seemed to be alright.The event of rash was added to the case.On an unknown date, the outcome of the rash was unknown.It was unknown if the reporter considered the rash to be related to polident 3 minute.

• Brand Name: POLIDENT 3 MINUTE
• 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: 7213064
• MDR Text Key: 98044709
• Report Number: 1020379-2018-00006
• 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: 01/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Date Manufacturer Received: 01/23/2018
• 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