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

Lot Number ASKU

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

Argus case: (b)(4).

Event Description

She swallowed the product/she took a sip with the product [accidental device ingestion] it's been 5-6 hours since the tablet was diluted in water [wrong technique in device usage process].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 female patient who received denture cleanser (polident denture cleanser tablets) tablet for product used for unknown indication.On an unknown date, the patient started polident denture cleanser tablets at an unknown dose and frequency.On an unknown date, an unknown time after starting polident denture cleanser tablets, the patient experienced accidental device ingestion (serious criteria gsk medically significant) and wrong technique in device usage process.The action taken with polident denture cleanser tablets was unknown.On an unknown date, the outcome of the accidental device ingestion and wrong technique in device usage process were unknown.It was unknown if the reporter considered the accidental device ingestion and wrong technique in device usage process to be related to polident denture cleanser tablets.Additional details: a lady called to tell that her daughter used the product polident cleaning effervescent tablet for her dental splints, she took a sip with the product, she forgot that she had put the polident tablet and she swallowed the product.She wanted to know if it was serious and was told her that question was send to the medical department about it.Also she had to see a doctor because she was not able to give medical advice.The patient agrees if the pv department contacts.She did not see a doctor, she did not have any symptoms.It's been 5-6 hours since the tablet was diluted in water.She did not keep the package.

• Brand Name: POLIDENT DENTURE CLEANSER TABLETS
• 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: 11038711
• MDR Text Key: 222649550
• Report Number: 1020379-2020-00063
• 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: 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/19/2020
• 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: 28 YR