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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 12/08/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Mother might have eat a piece of the polident table [accidental device ingestion] case description: this case was reported by a consumer and described the occurrence of accidental device ingestion in a (b)(6) female patient who received double salt denture cleanser (polident) tablet (batch number unk, expiry date unknown) for product used for unknown indication.On (b)(6) 2017, the patient started polident.On (b)(6) 2017, less than a day after starting polident, the patient experienced accidental device ingestion (serious criteria gsk medically significant).On an unknown date, the outcome of the accidental device ingestion was unknown.It was unknown if the reporter considered the accidental device ingestion to be related to polident.Additional details, adverse event information was received on (b)(6) 2017.The patient son reported for his mother stating, "my mother might have eat a piece of the polident overnight denture cleanser tablets, not sure though what could happen?".Follow information was received on 12 december 2017.The patient details were updated.Initial and follow up information was updated in the above narrative.

• 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: 7125288
• MDR Text Key: 95203355
• Report Number: 1020379-2017-00082
• 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: 12/08/2017

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: 12/08/2017
• Initial Date FDA Received: 12/18/2017
• 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
• Patient Age: 86 YR