MAUDE Adverse Event Report: GLAXOSMITHKLINE DUNGARVAN LTD ULTRA COREGA CREAM MINT FLAVOR; DENTURE ADHESIVE

Lot Number DE9772

Device Problem Use of Device Problem (1670)

Patient Problem Cancer (3262)

Event Type  Injury  

Manufacturer Narrative

3003721894-2019-00022 is associated with argus case (b)(4), ultra corega cream mint flavor.Ultra corega cream mint flavor is marketed in the us as super poligrip.

Event Description

Lymph nodes cancer [cancer of lymph node].Misuse [device used for unapproved schedule].Product complaint.Case description: this case was reported by a consumer via call center representative and described the occurrence of cancer of lymph node in a (b)(6)-year-old female patient who received double salt dental adhesive cream (ultra corega cream mint flavor) cream (batch number de9772, expiry date june 2021) for product used for unknown indication.This case was associated with a product complaint.Co-suspect products included double salt dental adhesive cream (ultra corega flavor free) cream (batch number dk1420, expiry date august 2021) for product used for unknown indication.The patient's past medical history included nodular (follicular) lymphoma.Previously administered products included corega tabs.Concurrent medical conditions included varicose vein (under treatment with diosmin.) and hematological infection (she undergoes laboratory tests every 6 months due to this.).Concomitant products included valsartan and diosmin.On an unknown date, the patient started ultra corega cream mint flavor and ultra corega flavor free at an unknown dose and frequency.In 2015, an unknown time after starting ultra corega cream mint flavor and ultra corega flavor free, the patient experienced cancer of lymph node (serious criteria gsk medically significant).On an unknown date, the patient experienced device used for unapproved schedule and product complaint.Ultra corega cream mint flavor was continued with no change.Ultra corega flavor free was continued with no change.On an unknown date, the outcome of the cancer of lymph node was recovered/resolved and the outcome of the device used for unapproved schedule and product complaint were unknown.It was unknown if the reporter considered the cancer of lymph node and device used for unapproved schedule to be related to ultra corega cream mint flavor.It was unknown if the reporter considered the cancer of lymph node to be related to ultra corega flavor free.Additional details: this report refers to a consumer who had been using ultra corega cream mint flavor and ultra corega flavor free since more than 10 years ago (did not specify).Due to the product presents with an adhesion problem depending on what she ate, she used it at least twice a day, although this was not recommended in the product label (misuse).Furthermore, she presented with lymph nodes cancer in 2015 (she was already consumer of this product) and she had to undergo chemotherapy as treatment.She had recovered from this event.Currently, she was still using the product.As additional information, she indicated that she was taking half tablet of valsartan 80 mg everyday (40 mg qd) as concomitant medication.It was unknown if the misuse was intentional or not.

Manufacturer Narrative

3003721894-2019-00022 is associated with argus case (b)(4), ultra corega cream mint flavor.Ultra corega cream mint flavor is marketed in the us as super poligrip.Device evaluation: on february 15th 2019, the qa department performed the complaint closure for issues (b)(4).The complaint will be closed as unsubstantiated.Details on the investigation were not provided.

Event Description

Case description: this case was reported by a consumer via call center representative and described the occurrence of cancer of lymph node in a 66-year-old female patient who received double salt dental adhesive cream (ultra corega cream mint flavor) cream (batch number de9772, expiry date june 2021) for product used for unknown indication.This case was associated with a product complaint.Co-suspect products included double salt dental adhesive cream (ultra corega flavor free) cream (batch number dk1420, expiry date august 2021) for product used for unknown indication.The patient's past medical history included nodular (follicular) lymphoma.Previously administered products included corega tabs.Concurrent medical conditions included varicose vein (under treatment with diosmin.) and hematological infection (she undergoes laboratory tests every 6 months due to this.).Concomitant products included valsartan and diosmin.On an unknown date, the patient started ultra corega cream mint flavor and ultra corega flavor free at an unknown dose and frequency.In 2015, an unknown time after starting ultra corega cream mint flavor and ultra corega flavor free, the patient experienced cancer of lymph node (serious criteria gsk medically significant).On an unknown date, the patient experienced device used for unapproved schedule and product complaint.Ultra corega cream mint flavor was continued with no change.Ultra corega flavor free was continued with no change.On an unknown date, the outcome of the cancer of lymph node was recovered/resolved and the outcome of the device used for unapproved schedule and product complaint were unknown.It was unknown if the reporter considered the cancer of lymph node and device used for unapproved schedule to be related to ultra corega cream mint flavor.It was unknown if the reporter considered the cancer of lymph node to be related to ultra corega flavor free.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 report refers to a consumer who had been using ultra corega cream mint flavor and ultra corega flavor free since more than 10 years ago (did not specify).Due to the product presents with an adhesion problem depending on what she ate, she used it at least twice a day, although this was not recommended in the product label (misuse).Furthermore, she presented with lymph nodes cancer in 2015 (she was already consumer of this product) and she had to undergo chemotherapy as treatment.She had recovered from this event.Currently, she was still using the product.As additional information, she indicated that she was taking half tablet of valsartan 80 mg everyday (40 mg qd) as concomitant medication.It was unknown if the misuse was intentional or not.Follow up was received from quality assurance department on 15 feb 2019, the patient received double salt dental adhesive cream (ultra corega cream mint flavor) cream (expiry date 30th june 2021) and double salt dental adhesive cream (ultra corega flavor free) cream (batch number dk1420, expiry date 31st august 2021).It was unknown if the reporter considered the device used for unapproved schedule to be related to ultra corega flavor free.Quality assurance analysis revealed the complaint to be unsubstantiated.

• Brand Name: ULTRA COREGA CREAM MINT FLAVOR
• Type of Device: DENTURE ADHESIVE
• Manufacturer (Section D): GLAXOSMITHKLINE DUNGARVAN LTD; dungarvan, waterford ; EI
• MDR Report Key: 8289666
• MDR Text Key: 134600061
• Report Number: 3003721894-2019-00022
• Device Sequence Number: 1
• Product Code: KOT
• 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,foreign
• Type of Report: Initial,Followup
• Report Date: 01/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2021
• Device Lot Number: DE9772
• Date Manufacturer Received: 02/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DIOSMIN UNKNOWN; VALSARTAN TABLET
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Weight: 59