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

Lot Number UNKNOWN

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

Mdr 1020379-2018-00072 is associated with argus case (b)(4), polident.

Event Description

We have a (b)(6) old that just drank the polident water (accidental device ingestion by a child).Case description: this case was reported by a consumer and described the occurrence of accidental device ingestion by a child in a (b)(6) year-old patient who received denture cleanser (polident) unknown for product used for unknown indication.On an unknown date, the patient started polident.On an unknown date, an unknown time after starting polident, the patient experienced accidental device ingestion by a child (serious criteria gsk medically significant).On an unknown date, the outcome of the accidental device ingestion by a child was unknown.It was unknown if the reporter considered the accidental device ingestion by a child to be related to polident.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 13 december 2018.The consumer reported that, "we have a (b)(6) year old that just drank the polident water.We think she may have.Should we call poison control or do you have any information? i don't think she drank too much i think she is fine." this report is being resubmitted to capture corrections for initial version dated on 13 december 2018.The patient demographic details were corrected.

• Brand Name: POLIDENT
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): BLOCK DRUG CO., INC.; memphismemphis TN
• Manufacturer Contact: po box 13398; research triangle park, NC 27709 ; 8888255249
• MDR Report Key: 8179170
• MDR Text Key: 130982593
• Report Number: 1020379-2018-00072
• 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: 12/13/2018

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: 12/13/2018
• Initial Date FDA Received: 12/19/2018
• 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
• Patient Age: 24 MO