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

Lot Number MF291624B

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Burning Sensation (2146); Reaction (2414); Sleep Dysfunction (2517)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Diabetic [diabetes], burning sensation during bowel movement [painful defecation], burning sensation on gums [burning gum], burning sensation while urinating [micturition burning], difficulty sleeping [difficulty sleeping], possible allergic reaction [allergic reaction], burning sensation [burning sensation].Case description: this case was reported by a consumer and described the occurrence of diabetes in a (b)(6) male patient who received double salt denture cleanser (polident overnight denture cleanser tablets) tablet (batch number mf291624b, expiry date 30th june 2019) for product used for unknown indication.Co-suspect products included double salt dental adhesive cream (super poligrip free denture adhesive cream) cream (batch number 6f6t, expiry date unknown) for product used for unknown indication.In 2016, the patient started polident overnight denture cleanser tablets and super poligrip free denture adhesive cream.On an unknown date, an unknown time after starting polident overnight denture cleanser tablets and super poligrip free denture adhesive cream, the patient experienced diabetes (serious criteria gsk medically significant), painful defecation, burning gum, micturition burning, difficulty sleeping, allergic reaction and burning sensation.The patient was treated with insulin nos (insulin).Polident overnight denture cleanser tablets was discontinued (dechallenge was unknown).Super poligrip free denture adhesive cream was discontinued (dechallenge was unknown).On an unknown date, the outcome of the diabetes, painful defecation, burning gum, micturition burning, difficulty sleeping, allergic reaction and burning sensation were unknown.It was unknown if the reporter considered the diabetes, painful defecation, burning gum, micturition burning and burning sensation to be related to polident overnight denture cleanser tablets and super poligrip free denture adhesive cream.The reporter considered the difficulty sleeping to be related to polident overnight denture cleanser tablets.The reporter considered the allergic reaction to be possibly related to polident overnight denture cleanser tablets and super poligrip free denture adhesive cream.It was unknown if the reporter considered the difficulty sleeping to be related to super poligrip free denture adhesive cream.Additional details, adverse event information was received on 27 april 2017.The consumer reported he started using super poligrip free 2.4 oz and polident overnight whitening about a year ago but he thought he might be allergic to it.Every morning when he apply dentures experienced a burning sensation on gums.He was told to gargle with salt water, so he did and reapplied dentures but the burning sensation returned.The burning sensation travels through body, and while peeing and releasing bowels he feel the sensation.He applied it one morning and the next morning when using the restroom experienced the burning sensation.While using this it also kept him from sleeping at night.Consumer did not clarify whether or not he developed diabetes prior to using super poligrip free 2.4 oz and the polident overnight whitening.Consumer was also unable to clarify start and stop dates.

• 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: 6548147
• MDR Text Key: 74596689
• Report Number: 1020379-2017-00036
• 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: 04/27/2017

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 Expiration Date: 06/30/2019
• Device Lot Number: MF291624B
• Initial Date Manufacturer Received: 04/27/2017
• Initial Date FDA Received: 05/05/2017
• 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: 66 YR