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

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

Patient Problem Nausea (1970)

Event Type  Injury  

Manufacturer Narrative

Argus case: (b)(4).

Event Description

He drank the effervescent tablet solution [accidental device ingestion].My father experienced vomiting [vomiting].Case description: this case was reported by a consumer via call center representative and described the occurrence of accidental device ingestion in a (b)(6) male patient who received denture cleanser (polident denture cleanser tablets) tablet (batch number unk, expiry date unknown) for product used for unknown indication.On an unknown date, the patient started polident denture cleanser tablets.On an unknown date, an unknown time after starting polident denture cleanser tablets, the patient experienced accidental device ingestion (serious criteria gsk medically significant and other: gsk medically significant) and vomiting.The action taken with polident denture cleanser tablets was unknown.On an unknown date, the outcome of the accidental device ingestion and vomiting were unknown.It was unknown if the reporter considered the accidental device ingestion and vomiting to be related to polident denture cleanser tablets.Additional information: the adverse event information was received from consumer on 16-aug-2021 via call center representative (phone).The consumer stated that "my father used the effervescent tablet solution for his dentures.He is quite old, (b)(6), and is quite forgetful.By mistake he drank the effervescent tablet solution.Will this have much of an effect? when questioned, [he admits] he experienced vomiting, but he refuses to go see a doctor.So, i am phoning to ask the call center instead".

• Brand Name: POLIDENT DENTURE CLEANSER TABLETS
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): BLOCK DRUG CO., INC.; memphis TN
• Manufacturer Contact: po box 13398; research triangle park, NC 27709 ; 8888255249
• MDR Report Key: 12405756
• MDR Text Key: 269383882
• Report Number: 1020379-2021-00044
• 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: 08/16/2021

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: 08/16/2021
• Initial Date FDA Received: 09/01/2021
• 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: 65 YR