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

Lot Number 2225A1

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

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

Event Date 12/09/2020

Event Type  Injury  

Manufacturer Narrative

Argus case: (b)(4).

Event Description

My son may have swallowed some [accidental device ingestion by a child] use of an expired product [expired device used] case description: this case was reported by a consumer via call center representative and described the occurrence of accidental device ingestion by a child in a (b)(6)-year-old male patient who received denture cleanser (polident retainer cleanser) tablet (batch number 2225a1, expiry date 31st july 2018) for drug use for unknown indication.On an unknown date, the patient started polident retainer cleanser.On (b)(6) 2020, an unknown time after starting polident retainer cleanser, the patient experienced accidental device ingestion by a child (serious criteria gsk medically significant).On an unknown date, the patient experienced expired device used.The action taken with polident retainer cleanser was unknown.On an unknown date, the outcome of the accidental device ingestion by a child and expired device used were unknown.It was unknown if the reporter considered the accidental device ingestion by a child and expired device used to be related to polident retainer cleanser.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details: consumer reported about polident for retainer.Consumer's son may have swallowed some because he used the same toothbrush consumer used to brush his retainer with the solution.Consumer did not realize it was expired.Consumer would just going to watch him and see.

• Brand Name: POLIDENT RETAINER CLEANSER
• 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: 11055085
• MDR Text Key: 223169374
• Report Number: 1020379-2020-00062
• 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: 12/09/2020

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: 07/31/2018
• Device Lot Number: 2225A1
• Initial Date Manufacturer Received: 12/09/2020
• Initial Date FDA Received: 12/22/2020
• 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
• Patient Age: 11 YR