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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

This report is associated with argus case (b)(4), polident.

Event Description

Mistakenly put a polident tablet in her glass of water instead of an alka-seltzer tablet and drank two gulps of it.My stomach really hurts.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) tablet (batch number unk, expiry date 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 (serious criteria gsk medically significant and other: gsk medically significant), stomach pain and accidental ingestion of drug.On an unknown date, the outcome of the accidental device ingestion, stomach pain and accidental ingestion of drug were unknown.It was unknown if the reporter considered the accidental device ingestion and stomach pain to be related to polident.Additional details, adverse event information received on 08 november 2016.Consumer reported having mistakenly put a polident tablet in her glass of water instead of an alka-seltzer tablet and drank two gulps of it.She reported that her stomach really hurt.

• Brand Name: POLIDENT
• 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: 6102921
• MDR Text Key: 59904405
• Report Number: 1020379-2016-00065
• 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: 11/08/2016

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: 11/08/2016
• Initial Date FDA Received: 11/15/2016
• 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