MAUDE Adverse Event Report: BLOCK DRUG CO., INC. POLIDENT 3 MINUTE TABLETS; DENTURE CLEANSER

Lot Number MC161814E

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Nausea (1970); Dizziness (2194)

Event Date 11/19/2018

Event Type  Injury  

Manufacturer Narrative

1020379-2018-00068 is associated with argus case (b)(6), polident 3 minute tablets.

Event Description

Why did it poison me? [poisoning].It left a horrible taste in my mouth.It is horrible distinguishing taste [after taste].I got nauseous and dizzy [nausea].I got nauseous and dizzy [dizziness].This is the three minute whitening and i used it for about nine minutes.[wrong technique in device usage process].Drug poisoning [drug poisoning].Case description: this case was reported by a consumer and described the occurrence of poisoning in a (b)(6)-year-old female patient who received denture cleanser (polident 3 minute tablets) tablet (batch number mc161814e, expiry date unknown) for denture wearer.On an unknown date, the patient started polident 3 minute tablets.On (b)(6) 2018, an unknown time after starting polident 3 minute tablets, the patient experienced poisoning (serious criteria gsk medically significant), after taste, nausea, dizziness and wrong technique in device usage process.The action taken with polident 3 minute tablets was unknown.On an unknown date, the outcome of the poisoning, after taste, nausea, dizziness and wrong technique in device usage process were unknown.The reporter considered the poisoning and after taste to be related to polident 3 minute tablets.It was unknown if the reporter considered the nausea, dizziness and wrong technique in device usage process to be related to polident 3 minute 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, adverse event information was received via call on (b)(6) 2018.Consumer reported that, "i used this polident denture cleanser and rinsed it and cleansed it.I was eating chocolate pudding.I got nauseous and dizzy.This is the three minute whitening and i used it for about nine minutes.Why did it poison me? it left a horrible taste in my mouth.It is horrible distinguishing taste.I am not going to use this what should i use?".

• Brand Name: POLIDENT 3 MINUTE 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: 8103184
• MDR Text Key: 128582828
• Report Number: 1020379-2018-00068
• Device Sequence Number: 1
• Product Code: EFT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: MC161814E
• Date Manufacturer Received: 11/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR