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

Lot Number JW5M

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Drank from the glass that had polident's cleansing tablet/swallowed two shots [accidental device ingestion] case description: this case was reported by a consumer via call center representative and described the occurrence of accidental device ingestion in a female patient who received denture cleanser (polident active oxygen) tablet (batch number jw5m, expiry date 31st october 2023) for product used for unknown indication.On an unknown date, the patient started polident active oxygen.On an unknown date, an unknown time after starting polident active oxygen, the patient experienced accidental device ingestion (serious criteria gsk medically significant).The action taken with polident active oxygen was unknown.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 active oxygen.Additional details: adverse event information was reported by consumer via call center representative(phone) on 29oct2021.The consumer stated," a mrs.Has called saying that she wanted to drink water and instantly realized that she drank from the glass that had polident's cleansing tablet.She says she swallowed two shots.She asks me how long we are going to take to give her an answer and if in this situation i am advising her to vomit.She can't talk to her doctor and also didn't want to give other personal details and has hung up the call.Ms.Said she wants a quick response and does not answer whether she agrees to be called by the pharmacovigilance department or not.She did not want to give me more personal data".

• Brand Name: POLIDENT ACTIVE OXYGEN
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): BLOCK DRUG CO., INC.; memphis TN
• MDR Report Key: 12752220
• MDR Text Key: 282524489
• Report Number: 1020379-2021-00062
• 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,foreign
• Type of Report: Initial
• Report Date: 10/29/2021

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 Expiration Date: 10/31/2023
• Device Lot Number: JW5M
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/29/2021
• Initial Date FDA Received: 11/04/2021
• 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