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

Lot Number MB191613A

Device Problem Use of Device Problem (1670)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

Report # 1020379-2017-00060 is associated with (b)(4), polident denture cleanser tablets.

Event Description

She just sipped a little of the polident 3-minute 84ct solution [accidental device ingestion].This case was reported by a consumer and described the occurrence of accidental device ingestion in a (b)(6)-year-old female patient who received double salt denture cleanser (polident denture cleanser tablets) tablet (batch number mb191613a, expiry date unknown) for dental cleaning.On an unknown date, the patient started polident denture cleanser tablets.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 accidental ingestion of drug.The action taken with polident denture cleanser tablets was unknown.On an unknown date, the outcome of the accidental device ingestion and accidental ingestion of drug were unknown.It was unknown if the reporter considered the accidental device ingestion to be related to polident denture cleanser tablets.Additional details, adverse event information was received on 01 august 2017.The consumer reported she just sipped a little of the polident 3-minute 84ct solution.She had it next to the glass where she had water to take her medication and accidentally drank the oral instead.

• Brand Name: POLIDENT DENTURE CLEANSER 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: 6768265
• MDR Text Key: 81903939
• Report Number: 1020379-2017-00060
• 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
• Type of Report: Initial
• Report Date: 08/01/2017

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?: No
• Device Operator: Lay User/Patient
• Device Lot Number: MB191613A
• Initial Date Manufacturer Received: 08/01/2017
• Initial Date FDA Received: 08/04/2017
• 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: 55 YR