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

Lot Number	16K284RGC
Health Effect - Clinical Codes	Fatigue (1849); Pain (1994); Burning Sensation (2146); Anxiety (2328); Depression (2361); Reaction (2414); Sleep Dysfunction (2517); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Report 1020379-2017-00035 is associated with argus case (b)(4), polident denture cleanser tablets.
Event or Problem Description
I feel like i don't want to live any more [suicidal ideation]; i might be having an allergic reaction to product [allergic reaction]; have an awful aftertaste in my mouth [after taste]; mouth feels hot [oral hot feeling]; mouth feels painful [oral pain]; exhausted [exhaustion]; flem [phlegm]; get up in the middle out the night/ i don't sleep at night [sleeplessness]; my tongue was sore [sore tongue].Case description: this case was reported by a consumer and described the occurrence of suicidal ideation in a (b)(6) female patient who received double salt denture cleanser (polident denture cleanser tablets) tablet (batch number 16k284rgc, expiry date 30th september 2019) for dental cleaning.In (b)(6) 2017, the patient started polident denture cleanser tablets.In (b)(6) 2017, an unknown time after starting polident denture cleanser tablets, the patient experienced after taste.On an unknown date, the patient experienced suicidal ideation (serious criteria gsk medically significant), allergic reaction, oral hot feeling, oral pain, exhaustion, phlegm, sleeplessness and sore tongue.Polident denture cleanser tablets was continued with no change.On an unknown date, the outcome of the suicidal ideation, allergic reaction, after taste, oral hot feeling, oral pain, exhaustion, phlegm, sleeplessness and sore tongue were not recovered/not resolved.It was unknown if the reporter considered the suicidal ideation, after taste, oral hot feeling, oral pain, exhaustion, phlegm, sleeplessness and sore tongue to be related to polident denture cleanser tablets.The reporter considered the allergic reaction to be possibly related to polident denture cleanser tablets.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details, this adverse event information was received on 27 april 2017.The consumer reported that, she had been using the product for about 2 months ((b)(6) 2017) and she thought she might be having an allergic reaction to the product.She had an awful aftertaste in her mouth that she had spoke to doctors about and she could not figure out why or where it was coming from.Her mouth felt hot, painful.She was exhausted because she had to get up in the middle out the night to spit out the flem.She did not sleep at night because of this.She felt like she did not want to live any more.She did not see a lot code on the top of the box.Her tongue was sore also.She was still using the product.She started noticing the taste for about two months ((b)(6) 2017).

• Brand Name: POLIDENT DENTURE CLEANSER TABLETS
• Common Device Name: DENTURE CLEANSER
• Manufacturer (Section D): BLOCK DRUG CO., INC.; 2149 harbor avenue; memphis TN 38113
• MDR Report Key: 6548217
• Report Number: 1020379-2017-00035
• Device Sequence Number: 1296698
• Product Code: EFT
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/30/2019
• Device Lot Number: 16K284RGC
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2017
• Initial Report FDA Received Date: 05/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR