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

Device Problem Use of Device Problem (1670)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

Number 1020379-2017-00064 is associated with argus case (b)(4), polident.

Event Description

Drank some of the polident solution when i was taking my pills [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) unknown (batch number unk, expiry date unknown) for product used for unknown indication.Concomitant products included calcium carbonate (tums).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 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.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 (b)(6) 2017.Consumer reported that "i drank some of the polident solution when i was taking my pills.I took some tums and i'm going to the doctor's later today".The concomitant medication included unspecified pills.

• 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: 6789234
• MDR Text Key: 82521422
• Report Number: 1020379-2017-00064
• 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: 08/08/2017

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: 08/08/2017
• Initial Date FDA Received: 08/11/2017
• 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