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

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

Patient Problem Choking (2464)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was choked up in the throat [choke on medication].Ate 2 tablets of the polident denture cleanser tablet; thought that it was a pill for soreness.[accidental device ingestion].Case description: this case was reported by a consumer via call center representative and described the occurrence of choke on medication in a (b)(6) year-old female patient who received denture cleanser (polident denture cleanser) tablet (batch number unk, expiry date unknown) for product used for unknown indication.Concurrent medical conditions included pain.On an unknown date, the patient started polident denture cleanser.On an unknown date, an unknown time after starting polident denture cleanser, the patient experienced choke on medication (serious criteria gsk medically significant) and accidental device ingestion (serious criteria gsk medically significant).The action taken with polident denture cleanser was unknown.On an unknown date, the outcome of the choke on medication and accidental device ingestion were unknown.It was unknown if the reporter considered the choke on medication and accidental device ingestion to be related to polident denture cleanser.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 received by a consumer via call center representative (phone) on 23-jul-2021, consume stated that "family member lives alone.When we came back from climbing the mountain, we found that family member b had something stuck in the throat, then learned that family member a asked family b to eat 2 tablets of the polident denture cleanser tablet.Family member a thought that it was a pill for soreness.Originally, family member a wanted family member b to eat 6 tablets, fortunately, when we rushed back, she only ate 2 of the tablets.What to do if accidentally eaten? when family member b just swallowed it, it was choked up in the throat, she kept drinking water, and took something to eat and swallow it down.Family member had used it before, i just bought it back, did not know that my family member would eat it by mistake.We did not go to see the doctor, family member b did not have any condition after swallowing 2 tablets".

• Brand Name: POLIDENT DENTURE CLEANSER
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): BLOCK DRUG CO., INC.; memphis TN
• Manufacturer Contact: po box 13398; research triangle, NC 27709 ; 8888255249
• MDR Report Key: 12330873
• MDR Text Key: 266864898
• Report Number: 1020379-2021-00040
• 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: 07/23/2021

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/23/2021
• Initial Date FDA Received: 08/17/2021
• 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: 80 YR