MAUDE Adverse Event Report: GLAXOSMITHKLINE DUNGARVAN LTD COREGA (UNSPECIFIED DENTURE ADHESIVE OR DENTURE CLEANSER); UNKNOWN

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

Patient Problem Vomiting (2144)

Event Type  Injury  

Manufacturer Narrative

Argus case (b)(4).

Event Description

Lung problem [lung disorder], vomiting [vomiting], she sweated [sweating], anxiety [anxiety], fever [fever], burning eyes [burning in eyes], i thought my head would break/headache [headache], i do not have strength to work [weakness], weight loss [weight loss], the product is almost disabling me [activities of daily living impaired], started to feel bad [feeling bad], product became "a drool" in my stomach [accidental ingestion of product].Case description: this case was reported by a consumer via call center representative and described the occurrence of lung disorder in a (b)(6)-year-old female patient who received corega (corega (unspecified denture adhesive or denture cleanser)) unknown for product used for unknown indication.In (b)(6) 2018, the patient started corega (unspecified denture adhesive or denture cleanser) at an unknown dose and frequency.On an unknown date, an unknown time after starting corega (unspecified denture adhesive or denture cleanser), the patient experienced lung disorder (serious criteria other: serious per reporter), vomiting (serious criteria other: serious per reporter), sweating (serious criteria other: serious per reporter), anxiety (serious criteria other: serious per reporter), fever (serious criteria other: serious per reporter), burning in eyes (serious criteria other: serious per reporter), headache (serious criteria other: serious per reporter), weakness (serious criteria other: serious per reporter), weight loss (serious criteria other: serious per reporter), activities of daily living impaired (serious criteria other: serious per reporter), feeling bad (serious criteria other: serious per reporter) and drooling (serious criteria other: serious per reporter).The action taken with corega (unspecified denture adhesive or denture cleanser) was unknown.On an unknown date, the outcome of the lung disorder, vomiting, sweating, anxiety, fever, burning in eyes, headache, weakness, weight loss, activities of daily living impaired, feeling bad and drooling were unknown.The reporter considered the lung disorder, vomiting, sweating, anxiety, fever, burning in eyes, headache, weakness and weight loss to be possibly related to corega (unspecified denture adhesive or denture cleanser).It was unknown if the reporter considered the activities of daily living impaired, feeling bad and drooling to be related to corega (unspecified denture adhesive or denture cleanser).Additional information: patient had used corega ultra without flavor 19g since (b)(6).Patient love this product, but it cause too many harm in her life.Patient had started to feel bad 3 months ago.It caused a lung problem.Patient vomited a gooey and white thing.Patient sweated like a pig.It was a dangerous product, which caused her anxiety and fever.Patient was with 41 degrees, burning eyes and patient thought her head would break.Patient did not have strength to work.Patient lost 20kg of weight.The product is almost disabling her.Patient went to her physician, but he informed that it was nothing.The physicians suspected that patient had aids because patient had all the symptoms that also seem like hepatitis.Since patient did not know what she vomited, patient took the vomit to the laboratory and they told her that symptoms occurred due to the product.Product became "a drool" in her stomach.Patient went to laboratory and they said that paste caused all of the symptoms.The symptoms seemed symptoms of hepatitis.Patient had the symptoms of hepatitis but the product was the causative of the symptoms.This case was linked to (b)(4) due to same reporter.

• Brand Name: COREGA (UNSPECIFIED DENTURE ADHESIVE OR DENTURE CLEANSER)
• Type of Device: UNKNOWN
• Manufacturer (Section D): GLAXOSMITHKLINE DUNGARVAN LTD; dungarvan,; waterford; EI
• Manufacturer Contact: po box 13398; research triangle park,; 8888255249
• MDR Report Key: 9260117
• MDR Text Key: 184307145
• Report Number: 3003721894-2019-00305
• Device Sequence Number: 1
• Product Code: KOT
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/14/2019

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: 10/14/2019
• Initial Date FDA Received: 10/31/2019
• 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: 71 YR