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

Lot Number MK301613B

Device Problem Use of Device Problem (1670)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

This report is associated with argus (b)(4), polident overnight denture cleanser tablets.

Event Description

Father ingested one of the tablets [accidental device ingestion].Case description: this case was reported by a consumer and described the occurrence of accidental device ingestion in a (b)(6) male patient who received double salt denture cleanser (polident overnight denture cleanser tablets) tablet (batch number mk301613b, expiry date unknown) for dental care.On (b)(6) 2017, the patient started polident overnight denture cleanser tablets.On (b)(6) 2017, an unknown time after starting polident overnight denture cleanser tablets, the patient experienced accidental ingestion of drug.On an unknown date, the patient experienced accidental device ingestion (serious criteria gsk medically significant).Polident overnight denture cleanser tablets was continued with no change.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 overnight denture cleanser tablets.Additional details, adverse event information was received on (b)(6) 2017.The patient used polident overnight denture cleanser tablets.The patient's daughter reported that her father ingested one of the tablets.She monitored him for about an hour.He did not seem to be in any distress.This all happened today ((b)(6) 2017).He had been self administering his denture regimen.He might had been confused being in and out of his resident home.

• Brand Name: POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS
• 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: 6506957
• MDR Text Key: 73231182
• Report Number: 1020379-2017-00033
• 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: 04/17/2017

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
• Device Lot Number: MK301613B
• Initial Date Manufacturer Received: 04/17/2017
• Initial Date FDA Received: 04/20/2017
• 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: 96 YR