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

Lot Number 8L4H

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

Patient Problem Abdominal Pain (1685)

Event Date 04/24/2020

Event Type  Injury  

Manufacturer Narrative

Argus case (b)(4).

Event Description

Mistakenly drunk my polident [accidental device ingestion].Vomited [vomiting].Diarrhea [diarrhea].Stomach pain [stomach pain].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) female patient who received denture cleanser (polident whitening tablets) tablet (batch number 8l4h, expiry date 31st july 2022) for dental care.On an unknown date, the patient started polident whitening tablets.On (b)(6) 2020, an unknown time after starting polident whitening tablets, the patient experienced accidental device ingestion (serious criteria gsk medically significant), vomiting, diarrhea and stomach pain.The action taken with polident whitening tablets was unknown.On an unknown date, the outcome of the accidental device ingestion, vomiting, diarrhea and stomach pain were unknown.It was unknown if the reporter considered the accidental device ingestion, vomiting, diarrhea and stomach pain to be related to polident whitening tablets.Additional details: patient mistakenly drunk polident around 3 am in the morning and after 3 hours she vomited, did not knew if something would happened to her, she may going to die or what.Patient had diarrhea and stomach pain.Patient contact doctor but with that corona virus going on she did not want to go to the hospital.She should contact the poison control to see what going to tell.

• Brand Name: POLIDENT WHITENING 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: 10065416
• MDR Text Key: 193326524
• Report Number: 1020379-2020-00026
• Device Sequence Number: 1
• Product Code: EFT
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 04/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 07/31/2022
• Device Lot Number: 8L4H
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/24/2020
• 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: 41 YR