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

Lot Number MI231613B

Device Problem Use of Device Problem (1670)

Patient Problem Injury (2348)

Event Date 05/26/2017

Event Type  Injury  

Manufacturer Narrative

This report is associated with argus case (b)(4), polident whitening tablets.

Event Description

Possible accidental ingestion [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) patient who received double salt denture cleanser (polident whitening tablets) tablet (batch number mi231613b, expiry date september 2019) for drug use for unknown indication.On (b)(6) 2017, the patient started polident whitening tablets.On (b)(6) 2017, 0 min after starting polident whitening tablets, the patient experienced accidental device ingestion (serious criteria gsk medically significant).Polident whitening tablets was discontinued on (b)(6) 2017 (dechallenge was unknown).On an unknown date, the outcome of the accidental device ingestion was not reported.It was unknown if the reporter considered the accidental device ingestion to be related to polident whitening 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: the reporter stated that her grandchildren might have accidently ingested some of the polident whitening tablets product, she was not sure of the exact number of tablets ingested but she said maybe 1 whole tablet was ingested by the 3 children.She stated that they were playing with it and that she gave them some milk to neutralize it.The reporter stated they were fine and playing now.She stated that the kids were 2 boys and 1 girl and provided their ages in no specific order as (b)(6).

Manufacturer Narrative

This report is associated with (b)(4), polident whitening tablets.Qa results from 09 june 2017: a review of internal records found no evidence of issues noted to have occurred during the packaging of the batch that would have contributed to the complaint issue reported.All sample evaluations performed throughout the packaging process were noted to have passed, meeting specifications per the product finished packaging specification.The retention samples were reviewed to verify correct display carton used for the packaging run applicable to the formula and intended market.All retention samples were determined to be representative of the printed components charged to the batch packaging run.Based on the complaint being associated with use of the product beyond the intended use and in conflict with product packaging use instructions and specific caution statements, this complaint is determined to be unsubstantiated as a product safety issue related to the product when used as intended.

Event Description

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) patient who received double salt denture cleanser (polident whitening tablets) tablet (batch number mi231613b, expiry date september 2019) for drug use for unknown indication.On (b)(6) 2017, the patient started polident whitening tablets.On (b)(6) 2017, 0 min after starting polident whitening tablets, the patient experienced accidental device ingestion (serious criteria gsk medically significant).Polident whitening tablets was discontinued on (b)(6) 2017 (dechallenge was unknown).On an unknown date, the outcome of the accidental device ingestion was not reported.It was unknown if the reporter considered the accidental device ingestion to be related to polident whitening tablets.Additional information: the reporter stated that her grandchildren might have accidently ingested some of the polident whitening tablets product, she was not sure of the exact number of tablets ingested but she said maybe 1 whole tablet was ingested by the 3 children.She stated that they were playing with it and that she gave them some milk to neutralize it.The reporter stated they were fine and playing now.She stated that the kids were 2 boys and 1 girl and provided their ages in no specific order as (b)(6).Follow-up information received on 09 june 2017: this case is associated with a product quality complaint.Final qa investigation deemed the complaint to be not substantiated.

• Brand Name: POLIDENT WHITENING TABLETS
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): BLOCK DRUG CO., INC.; 2149 harbor avenue; memphis TN 38113
• Manufacturer (Section G): GSK
• Manufacturer Contact: po box 13398; research triangle park, NC 27709 ; 8888255249
• MDR Report Key: 6615469
• MDR Text Key: 76820796
• Report Number: 1020379-2017-00045
• 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,Followup
• Report Date: 05/26/2017

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?: Yes
• Device Operator: No Information
• Device Lot Number: MI231613B
• Initial Date Manufacturer Received: 05/26/2017
• Initial Date FDA Received: 06/06/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/16/2017
• Was Device Evaluated by Manufacturer?: No
• 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: 5 YR