MAUDE Adverse Event Report: GLAXOSMITHKLINE LLC POLIDENT DENTU CREME; DENTURE CLEANSER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Obstruction/Occlusion (2422)

Event Type  Injury  

Manufacturer Narrative

Mfr report 1314819-2017-00001 is associated with argus case (b)(4), polident dentu creme.

Event Description

I had to have surgery on the roof of my mouth for a blocked salivary gland and wondered if maybe the dentu creme was the culprit [salivary duct obstruction], i had to have surgery on the roof of my mouth for a blocked salivary gland and wondered if maybe the dentu creme was the culprit [salivary gland operation].Case description: this case was reported by a consumer and described the occurrence of salivary duct obstruction in a (b)(6) female patient who received double salt denture cleanser (polident dentu creme) cream (batch number unk, expiry date unknown) for product used for unknown indication.Concomitant products included no therapy.In 1960, the patient started polident dentu creme.On an unknown date, an unknown time after starting polident dentu creme, the patient experienced salivary duct obstruction (serious criteria other) and salivary gland operation (serious criteria gsk medically significant and other).On an unknown date, the outcome of the salivary duct obstruction and salivary gland operation were unknown.The reporter considered the salivary duct obstruction and salivary gland operation to be possibly related to polident dentu creme.Additional details, the adverse event information was received on via email on 9 april 2017.Consumer reported using polident dentu creme.No lot code and expiration date was provided.Consumer reported that she was (b)(6).Consumer reported that she had been using the product since she was 18.Consumer reported that she had to have surgery on the roof of her mouth for a blocked salivary gland and wondered if might be the dentu creme was the culprit.The action taken for polident dentu crème was unknown.

Manufacturer Narrative

This report is associated with argus case (b)(4), polident dentu creme.

Event Description

Case description: this case was reported by a consumer and described the occurrence of salivary duct obstruction in a (b)(6) female patient who received double salt denture cleanser (polident dentu creme) cream (batch number unk, expiry date unknown) for product used for unknown indication.Concomitant products included no therapy.In 1960, the patient started polident dentu creme.On an unknown date, an unknown time after starting polident dentu creme, the patient experienced salivary duct obstruction (serious criteria other) and salivary gland operation (serious criteria gsk medically significant and other).On an unknown date, the outcome of the salivary duct obstruction and salivary gland operation were unknown.The reporter considered the salivary duct obstruction and salivary gland operation to be possibly related to polident dentu creme.Additional details, the adverse event information was received on via email on 9 april 2017.Consumer reported using polident dentu creme.No lot code and expiration date was provided.Consumer reported that she was (b)(6).Consumer reported that she had been using the product since she was 18.Consumer reported that she had to have surgery on the roof of her mouth for a blocked salivary gland and wondered if might be the dentu creme was the culprit.The action taken for polident dentu crème was unknown.Follow up information was received on 10 july 2017 from patient.The patient returned authorization form with the contact details of physician.The patient stated that she had been using this denture cleanser since it first came on the market.The consumer provided her surgery information since this lump was removed and doctor verified she had another lump (plugged gland).She stated that since dentu cream had been taken off the market, she wondered if it could be the cause of her problem.She had worn dentures since she was 18 years old now she was (b)(6).No more information was provided.

Manufacturer Narrative

1314819-2017-00001 is associated with argus case (b)(4), polident dentu creme.

Event Description

I had to have surgery on the roof of my mouth for a blocked salivary gland and wondered if maybe the dentu creme was the culprit/ plugged gland [salivary duct obstruction].I had to have surgery on the roof of my mouth for a blocked salivary gland and wondered if maybe the dentu creme was the culprit/ this lump was removed [salivary gland operation].Doctor verified i have another lump (plugged gland) [mass].Salivary gland duct with surrounding fibrosis [fibrosis].Salivary gland duct with surrounding fibrosis and chronic inflammation [salivary duct inflammation].Overlying squamous mucosa with parakeratosis and squamous hyperplasia [hyperplasia].Overlaying squamous mucosa with parakeratosis/asymptomatic blue submucosal nodule [oral mucosal disorder].Case description: this case was reported by a consumer and described the occurrence of salivary duct obstruction in a (b)(6)-year-old female patient who received double salt denture cleanser (polident dentu creme) cream (batch number unk, expiry date unknown) for product used for unknown indication.Concomitant products included no therapy.In 1960, the patient started polident dentu creme.On an unknown date, an unknown time after starting polident dentu creme, the patient experienced salivary duct obstruction (serious criteria other) and salivary gland operation (serious criteria gsk medically significant and other).On an unknown date, the outcome of the salivary duct obstruction and salivary gland operation were unknown.The reporter considered the salivary duct obstruction and salivary gland operation to be possibly related to polident dentu creme.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details: the adverse event information was received on via email on 9 april 2017.Consumer reported using polident dentu creme.No lot code and expiration date was provided.Consumer reported that she was (b)(6) years old.Consumer reported that she had been using the product since she was 18.Consumer reported that she had to have surgery on the roof of her mouth for a blocked salivary gland and wondered if might be the dentu creme was the culprit.The action taken for polident dentu crème was unknown.Follow up information was received on 10 july 2017 from patient.The patient returned authorization form with the contact details of physician.The patient stated that she had been using this denture cleanser since it first came on the market.The consumer provided her surgery information since this lump was removed and doctor verified she had another lump (plugged gland).She stated that since dentu cream had been taken off the market, she wondered if it could be the cause of her problem.She had worn dentures since she was 18 years old now she was (b)(6) years old.No more information was provided.Follow up information was received on 27 sep 2017 from the patient's dentist via adverse event report (aer) form.The form was returned signed by the dentist, medically confirming the case.The dentist reported that the "patient wears denture day and night a known cause for salivary duct obstruction." the aer form included a surgical pathology report collected on 10/11/2016.A soft tissue, designated as left greater hard/soft palate, biopsy was performed and the results showed cystically dilated salivary gland duct with surrounding fibrosis (fibrosis added as an event) and chronic inflammation (salivary duct inflammation added as an event).The results also showed overlying squamous mucosa with parakeratosis (oral mucosal disorder added as an event) and squamous hyperplasia (hyperplasia added as an event) and no neoplasm.The patient had a pre-procedure diagnosis of asymptomatic blue submucosal nodule (oral mucosal disorder) left hard/soft palate for at least one month.In 1960, the patient started polident dentu creme.On an unknown date, an unknown time after starting polident dentu creme, the patient experienced salivary duct obstruction (serious criteria other), salivary gland operation (serious criteria gsk medically significant and other: gsk medically significant), mass, fibrosis, salivary duct inflammation, hyperplasia, oral mucosal disorder and oral nodule.On an unknown date, the outcome of the salivary duct obstruction, salivary gland operation, mass, fibrosis, salivary duct inflammation, hyperplasia and oral mucosal disorder were unknown.The reporter considered the salivary duct obstruction, salivary gland operation and mass to be possibly related to polident dentu creme.It was unknown if the reporter considered the fibrosis, salivary duct inflammation, hyperplasia and oral mucosal disorder to be related to polident dentu creme.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.

Event Description

Case description: this case was reported by a consumer and described the occurrence of salivary duct obstruction in a (b)(6) female patient who received double salt denture cleanser (polident dentu creme) cream (batch number unk, expiry date unknown) for product used for unknown indication.Concomitant products included no therapy.In 1960, the patient started polident dentu creme.On an unknown date, an unknown time after starting polident dentu creme, the patient experienced salivary duct obstruction (serious criteria other), salivary gland operation (serious criteria gsk medically significant and other: gsk medically significant), mass, fibrosis, salivary duct inflammation, hyperplasia, oral mucosal disorder and oral nodule.On an unknown date, the outcome of the salivary duct obstruction, salivary gland operation, mass, fibrosis, salivary duct inflammation, hyperplasia and oral mucosal disorder were unknown.The reporter considered the salivary duct obstruction, salivary gland operation and mass to be possibly related to polident dentu creme.It was unknown if the reporter considered the fibrosis, salivary duct inflammation, hyperplasia and oral mucosal disorder to be related to polident dentu creme.Additional details, the adverse event information was received on via email on 9 april 2017.Consumer reported using polident dentu creme.No lot code and expiration date was provided.Consumer reported that she was (b)(6).Consumer reported that she had been using the product since she was (b)(6).Consumer reported that she had to have surgery on the roof of her mouth for a blocked salivary gland and wondered if might be the dentu creme was the culprit.The action taken for polident dentu crème was unknown.Follow up information was received on (b)(6) 2017 from patient.The patient returned authorization form with the contact details of physician.The patient stated that she had been using this denture cleanser since it first came on the market.The consumer provided her surgery information since this lump was removed and doctor verified she had another lump (plugged gland).She stated that since dentu cream had been taken off the market, she wondered if it could be the cause of her problem.She had worn dentures since she was (b)(6) now she was (b)(6).No more information was provided.Follow up information was received on 27 sep 2017 from the patient's dentist via adverse event report (aer) form.The form was returned signed by the dentist, medically confirming the case.The dentist reported that the "patient wears denture day and night a known cause for salivary duct obstruction." the aer form included a surgical pathology report collected on (b)(6) 2016.A soft tissue, designated as left greater hard/soft palate, biopsy was performed and the results showed cystically dilated salivary gland duct with surrounding fibrosis (fibrosis added as an event) and chronic inflammation (salivary duct inflammation added as an event).The results also showed overlying squamous mucosa with para keratosis (oral mucosal disorder added as an event) and squamous hyperplasia (hyperplasia added as an event) and no neoplasm.The patient had a pre-procedure diagnosis of asymptomatic blue sub mucosal nodule (oral mucosal disorder) left hard/soft palate for at least one month.Follow-up information was received from the dentist on 21 december 2017 via the adverse event report (aer) form.The dentist medically confirmed the previously reported information through 10 july 2017 by signing and returning the form.Included with the form was a referral form for "spot on roof of mouth." also included with the form was a medical record dated (b)(6) 2016, which stated, "patient presents today for evaluation lesion roof of mouth.Patient stated dentist noticed lesion 1 month ago.Patient relates no pain or change in size/color" (oral disorder was previously reported).Additional medical history included hay fever/sinus issues (hay fever, sinus disorder), high cholesterol, swollen ankles/arthritis (ankle swelling, arthritis), osteoporosis/osteopenia, stomach ulcers (gastric ulcer), on a diet, cataract surgery (cataract extraction), pain/clicking in jaw (jaw pain, jaw clicking).Allergies included augmentin, amoxicillins, sulfites, sulfa drugs, lactose, seasonal, z-pack and vytorin (augmentin, amoxicillin, lactose and z-pak were added as co-suspect medications; new event of drug allergy was added).The patient reported 0/10 pain.Per the exam the dentist wrote, "edentulous max (maxilla) with 5mm submucosal nodule at junction of hard and soft palate, firm and non-tender, bluish hue" (added new event of palatal nodule).Per the assessment the dentist recorded, "mucocele vs other (venous lake, salivary gland pathology)" (added new event of possible mucocele of mouth, added new event of possible venous lake).Per the plan, the dentist wrote, "excisional bx (biopsy) under la (local anesthesia), consent s/w, 1 carp (carpule) each 2% lido w epi (lidocaine with epinephrine) 0.5% marcaine w epi (marcaine with epinephrine), 5mm punch, bx (biopsy) removed w pick ups and tenotomy, agno3 (silver nitrate), gauze hemo poig rx per chart f/u (follow-up) 7-10d (days) for re eval (re-evaluation)" (treatment products lidocaine with epinephrine, marcaine with epinephrine and silver nitrate were added).On an unknown date, the outcome of the drug allergy, oral disorder, palatal nodule, possible mucocele of mouth, possible venous lake were unknown.It was unknown if the reporter considered the oral disorder, palatal nodule, possible mucocele of mouth, possible venous lake to be related to the polident dentu cream.The reporter considered the drug allergy to be related to augmentin, amoxicillin, lactose and z-pak.

• Brand Name: POLIDENT DENTU CREME
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): GLAXOSMITHKLINE LLC; 3169 route 145; east durham NY 12423
• MDR Report Key: 6494672
• MDR Text Key: 72854391
• Report Number: 1314819-2017-00001
• 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,health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/09/2017

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: 04/09/2017
• Initial Date FDA Received: 04/14/2017
• Supplement Dates Manufacturer Received: 07/10/2017; 09/27/2017; 12/21/2017
• Supplement Dates FDA Received: 07/17/2017; 10/06/2017; 01/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NO THERAPY; NO THERAPY
• Patient Outcome(s): Other
• Patient Age: 75 YR
• Patient Weight: 71