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

Device Problem Insufficient Information (3190)

Patient Problem Glaucoma (1875)

Event Type  Injury  

Manufacturer Narrative

This report is associated with argus case (b)(4), polident overnight denture cleanser tablets.

Event Description

The glaucoma came while using the polident [glaucoma].Case description: this case was reported by a consumer and described the occurrence of glaucoma in a female patient who received double salt denture cleanser (polident overnight denture cleanser tablets) tablet (batch number unk, expiry date unknown) for dental cleaning.On an unknown date, the patient started polident overnight denture cleanser tablets.On an unknown date, an unknown time after starting polident overnight denture cleanser tablets, the patient experienced glaucoma (serious criteria gsk medically significant).Polident overnight denture cleanser tablets was continued with no change.On an unknown date, the outcome of the glaucoma was unknown.It was unknown if the reporter considered the glaucoma to be related to polident overnight denture cleanser tablets.Additional details: adverse event information was received on (b)(6) 2017.Consumer reported "polident overnight whitening 84ct lot and expiration date was unknown.Po overnight; i buy this and i usually buy the 84 caplets.I ended up buying the 120 tablets.Did this always have a mint smell.Did they change the formula mint wise because it smells more minty.I live by myself and my glaucoma medicine takes majority of it so i want to be mindful of when i can call in.No the glaucoma came while using the polident.Is it possible that could happen".

• Brand Name: POLIDENT OVERNIGHT 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: 6723651
• MDR Text Key: 80383209
• Report Number: 1020379-2017-00054
• 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: 07/13/2017

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
• Initial Date Manufacturer Received: 07/13/2017
• Initial Date FDA Received: 07/18/2017
• 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