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

Lot Number UNKNOWN

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

Patient Problem Sore Throat (2396)

Event Date 12/30/2019

Event Type  Injury  

Manufacturer Narrative

Argus case (b)(4).

Event Description

I had a patient who accidentally swallowed a polident denture tablet [accidental device ingestion], she has a sore throat [sore throat].Case description: this case was reported by a dentist and described the occurrence of accidental device ingestion in a female patient who received denture cleanser (polident denture cleanser tablets) tablet (batch number unknown, expiry date unknown) for product used for unknown indication.On an unknown date, the patient started polident denture cleanser tablets.On (b)(6) 2019, an unknown time after starting polident denture cleanser tablets, the patient experienced accidental device ingestion (serious criteria gsk medically significant).On an unknown date, the patient experienced sore throat.The action taken with polident denture cleanser tablets was unknown.On an unknown date, the outcome of the accidental device ingestion and sore throat were unknown.It was unknown if the reporter considered the accidental device ingestion and sore throat to be related to polident denture cleanser tablets.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional information: adverse event information was received on 31 december 2019 via call.The reporter stated that, "i had a patient call me and i am calling for her.I had a patient who accidentally swallowed a polident denture tablet.They told her to call poison control.She has a sore throat.It happened last night at 10:30 pm.I am her dentist.I do not want to give her information without her permission.".

• Brand Name: POLIDENT 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; 8888255249
• MDR Report Key: 9607336
• MDR Text Key: 189835683
• Report Number: 1020379-2020-00001
• Device Sequence Number: 1
• Product Code: EFT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 12/31/2019

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: No Information
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/31/2019
• Initial Date FDA Received: 01/20/2020
• 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