MAUDE Adverse Event Report: BLOCK DRUG CO., INC.; POLIDENT 5MIN QUICK PLUS CLEANSER

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Ingested polident cleanser, thinking that it was a candy [accidental device ingestion] case description: this case was reported by a consumer via call center representative and described the occurrence of accidental device ingestion in a female patient who received denture cleanser (polident 5min quick plus cleanser) tablet (batch number unk, expiry date unknown) for product used for unknown indication.On an unknown date, the patient started polident 5min quick plus cleanser.On an unknown date, an unknown time after starting polident 5min quick plus cleanser, 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 5min quick plus cleanser.Additional details: adverse event information was received from a consumer via call center representative (phone) on 27oct2021.The reporter's mother has ingested polident cleanser, thinking that it was a candy.As the type of cleaner could not be confirmed, it has been registered as 5min quick plus.

• Type of Device: POLIDENT 5MIN QUICK PLUS CLEANSER
• Manufacturer (Section D): BLOCK DRUG CO., INC.; memphis TN
• MDR Report Key: 12752243
• MDR Text Key: 282201293
• Report Number: 1020379-2021-00061
• 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,foreign
• Type of Report: Initial
• Report Date: 10/27/2021

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: 10/27/2021
• Initial Date FDA Received: 11/04/2021
• 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