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

Lot Number 4013

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

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Argus case (b)(4).

Event Description

Has swallowed the water contained in the tablet [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 (b)(6)-year-old male patient who received denture cleanser (polident active oxygen) tablet (batch number 4013, expiry date 31st december 2021) 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: a consumer called to ask if anything could happen if the water containing the tablet to clean the polident prosthesis was swallowed.Consumer had stated that he had no symptoms and agreed to be contact by pv for additional information.Follow up information was received from consumer on 29 nov 2019: no new information was received.Patient said he has not had any more problems.Follow up information was received from consumer on 09 dec 2019: the reporter answered the phone.He said that he consulted a nurse for the side effects, but she told him to call the company.He also stated that he did not had any other symptoms, that he loved the product and continued to use it normally.No new medically significant information was received.

• Brand Name: POLIDENT ACTIVE OXYGEN
• 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: 9500356
• MDR Text Key: 188993128
• Report Number: 1020379-2019-00058
• Device Sequence Number: 1
• Product Code: EFT
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 12/31/2021
• Device Lot Number: 4013
• Initial Date Manufacturer Received: 11/25/2019
• Initial Date FDA Received: 12/20/2019
• 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: 67 YR