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

Device Problem Use of Device Problem (1670)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

This report is associated with (b)(4), polident 3 minute.

Event Description

Consumer reported her husband drank polident 3-minute [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).The action taken with polident 3 minute was unknown.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.Additional information: adverse event information was received on 14 december 2017.Consumer reported, "consumer reported her husband drank polident 3 minute.She gave him milk and induced vomiting.".

• 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
• MDR Report Key: 7772831
• MDR Text Key: 116755003
• Report Number: 1020379-2018-00043
• Device Sequence Number: 1
• Product Code: EFT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/14/2017

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
• Initial Date Manufacturer Received: 12/14/2017
• Initial Date FDA Received: 08/10/2018
• 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