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

Lot Number UNKNOWN

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Itching Sensation (1943)

Event Date 10/24/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

I took a drink to swallow the pill and i drank the polident [accidental device ingestion] i just have itching but i always get itchy [pruritus].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 denture cleanser (polident overnight denture cleanser tablets) tablet (batch number unknown, expiry date unknown) for denture wearer.On an unknown date, the patient started polident overnight denture cleanser tablets.On (b)(6) 2018, an unknown time after starting polident overnight denture cleanser tablets, the patient experienced accidental device ingestion (serious criteria gsk medically significant) and pruritus.The action taken with polident overnight denture cleanser tablets was unknown.On an unknown date, the outcome of the accidental device ingestion and pruritus were unknown.It was unknown if the reporter considered the accidental device ingestion and pruritus to be related to polident overnight denture cleanser tablets.Additional information, adverse event information was received via call on 25 october 2018.Consumer reported that, "i did something really stupid.I uh, it was dark and i took a pill and i had my dentures in with the polident.I took a drink to swallow the pill and i drank the polident.I just have itching but i always get itchy.I do not have the box i think it is the 40 ct.".

• Brand Name: POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): BLOCK DRUG CO., INC.; memphis TN
• Manufacturer Contact: po box 13398; research triangle park, NC 27709 ; 8888255249
• MDR Report Key: 8023065
• MDR Text Key: 125602012
• Report Number: 1020379-2018-00065
• 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: 10/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 10/25/2018
• 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: 61 YR