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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Chemical Exposure (2570); Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Manufacturer Narrative

Mfr 1020379-2017-00062 is associated with argus case (b)(4), polident denture cleanser tablets.

Event Description

I drank the polident [accidental device ingestion].Case description: this case was reported by a consumer and described the occurrence of accidental device ingestion in a female patient who received double salt denture cleanser (polident denture cleanser tablets) tablet (batch number unk, expiry date unknown) for product used for unknown indication.On an unknown date, the patient started polident denture cleanser tablets.On an unknown date, an unknown time after starting polident denture cleanser tablets, the patient experienced accidental device ingestion (serious criteria gsk medically significant) and accidental ingestion of drug.On an unknown date, the outcome of the accidental device ingestion and accidental ingestion of drug were unknown.It was unknown if the reporter considered the accidental device ingestion to be related to polident denture cleanser tablets.Additional details, adverse event information was received on 02 august 2017.The consumer stated, "i thought i was fixing alka-seltzer or i thought it was but it instead was the polident and i drank the polident".

Manufacturer Narrative

1020379-2017-00062 is associated with argus case (b)(4), polident denture cleanser tablets.Follow-up information received on 14 september 2017.The report confirmed that the suspect product was polident 3 minute tablets (initially reported as polident denture cleanser tablets).

Event Description

Case description: this case was reported by a consumer and described the occurrence of accidental device ingestion in a female patient who received double salt denture cleanser (polident denture cleanser tablets) tablet (batch number unk, expiry date unknown) for product used for unknown indication.On an unknown date, the patient started polident denture cleanser tablets.On an unknown date, an unknown time after starting polident denture cleanser tablets, the patient experienced accidental device ingestion (serious criteria gsk medically significant) and accidental ingestion of drug.On an unknown date, the outcome of the accidental device ingestion and accidental ingestion of drug were 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 details, adverse event information was received on 02 august 2017.The consumer stated, "i thought i was fixing alka-seltzer or i thought it was but it instead was the polident and i drank the polident".Follow up information was received on 14 september 2017.The consumer stated it was the polident 3 minute.Poison control cleared her and stated that she did not need to go to the doctors.No lot number was provided as those were the last of the tablets she had at the time.The suspect product was updated from "polident denture cleanser tablets" to "polident 3 minute".

• Brand Name: POLIDENT 3 MINUTE
• 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: 6776436
• MDR Text Key: 82150319
• Report Number: 1020379-2017-00062
• 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,Followup
• Report Date: 08/02/2017

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: 08/02/2017
• Initial Date FDA Received: 08/09/2017
• Supplement Dates Manufacturer Received: 09/14/2017
• Supplement Dates FDA Received: 09/21/2017
• 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