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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Diarrhea (1811); Pain (1994)

Event Date 06/13/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Accidental ingestion of device [accidental device ingestion].Diarrhea [diarrhea].Stomach pain [stomach pain].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) unknown (batch number unk, expiry date unknown) for dental cleaning.On (b)(6) 2016, the patient started polident.On (b)(6) 2016, an unknown time after starting polident, the patient experienced accidental device ingestion (serious criteria gsk medically significant) and diarrhea.On (b)(6) 2016, the patient experienced stomach pain.The action taken with polident was unknown (dechallenge was unknown).On an unknown date, the outcome of the accidental device ingestion, diarrhea and stomach pain were not recovered/not resolved.It was unknown if the reporter considered the diarrhea and stomach pain to be related to polident.Additional information: on (b)(6) 2016, consumer had used denture cleanser to put her dentures.She had accidently swallowed some of the product.On (b)(6) 2016 she had diarrhea at night.Today (b)(6) 2016 she had stomach pain.Revision made 19 july 2016.The causality for accidental device ingestion was changed from not applicable to unknown.This change results in a medwatch device report being generated.

• 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: 5812704
• MDR Text Key: 50177318
• Report Number: 1020379-2016-00024
• 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: 06/14/2016

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: 06/14/2016
• Initial Date FDA Received: 07/21/2016
• 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