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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Burning Sensation (2146); Dysuria (2684)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Mother drank what she thought was alka seltzer [accidental device ingestion].Burns when urinates/ urinary pain [micturition burning].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 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), micturition burning and accidental ingestion of drug.On an unknown date, the outcome of the accidental device ingestion, micturition burning and accidental ingestion of drug were unknown.It was unknown if the reporter considered the accidental device ingestion and micturition burning to be related to polident.Additional details, this adverse event information was received on 12 september 2016.The consumer reported that, accidental ingestion of product by adult as he stated that his mother drank what she thought was alka seltzer, but it was polident.The consumer reported urinary pain as he stated that his mother said that it was painful when she urinated.The consumer reported that, his mom said that it burned when she urinated.

• 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: 5974038
• MDR Text Key: 55569610
• Report Number: 1020379-2016-00040
• 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: 09/12/2016

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: 09/12/2016
• Initial Date FDA Received: 09/23/2016
• 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