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

Lot Number UNKNOWN

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

1020379-2018-00076 is associated with argus case (b)(6), polident 3 minute.

Event Description

My husband drank accidentally 2 sips of the polident solution [accidental device ingestion].Case description: this case was reported by a consumer and described the occurrence of accidental device ingestion in a male patient who received 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).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 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 information, adverse event information was received via call on (b)(6) 2018.The patient's wife called in about polident 3 minute and reported that, "my husband drank accidentally 2 sips of the polident solution.What should i do.".

• Brand Name: POLIDENT 3 MINUTE
• 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: 8184620
• MDR Text Key: 131020283
• Report Number: 1020379-2018-00076
• 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
• Report Date: 12/17/2018

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
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 12/17/2018
• Initial Date FDA Received: 12/20/2018
• 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