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

Lot Number MI131424A

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 11/30/2017

Event Type  Injury  

Manufacturer Narrative

Number 1020379-2017-00080 is associated with argus case us2017184374, polident denture cleanser tablets.

Event Description

She accidently picked up the cup that had the polident 3 minute tablet mixture in it and drank a little more than a sip [accidental device ingestion].Case description: this case was reported by a consumer and described the occurrence of accidental device ingestion in a (b)(6) female patient who received double salt denture cleanser (polident denture cleanser tablets) tablet (batch number mi131424a, expiry date unknown) for dental cleaning.On an unknown date, the patient started polident denture cleanser tablets.On (b)(6) 2017, an unknown time after starting polident denture cleanser tablets, the patient experienced accidental device ingestion (serious criteria gsk medically significant).Polident denture cleanser tablets was continued with no change.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 denture cleanser tablets.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 phone call on (b)(6) 2017.Consumer stated that she has been using the product to clean her dentures for years.She had two cups of liquid side by side and she accidently picked up the cup that had the polident 3 minute tablet mixture in it and drank a little more than a sip and swallowed it on (b)(6) 2017.She feels fine and was just scared.She stated she will continue to use the tablets to clean her dentures just will not accidently drink and swallow the mixture.

• Brand Name: POLIDENT DENTURE CLEANSER TABLETS
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): BLOCK DRUG CO., INC.; 2149 harbor avenue; memphis TN 38113
• Manufacturer (Section G): GSK
• Manufacturer Contact: po box 13398; research triangle park, NC 27709 ; 8888255249
• MDR Report Key: 7108208
• MDR Text Key: 94535708
• Report Number: 1020379-2017-00080
• 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: 11/30/2017

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
• Device Lot Number: MI131424A
• Initial Date Manufacturer Received: 11/30/2017
• Initial Date FDA Received: 12/12/2017
• 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: 64 YR