MAUDE Adverse Event Report: GLAXOSMITHKLINE DUNGARVAN LTD COREGA ULTRA CREAM WITHOUT FLAVOR; DENTURE ADHESIVE

Lot Number DL1648

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

Patient Problem Vomiting (2144)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Lung problem [lung disorder], vomiting [vomiting], 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 [strength loss of], weight loss [weight loss], started to feel bad [feeling bad], product became "a drool" in my stomach [accidental ingestion of product], the product is almost disabling me [activities of daily living impaired].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 double salt dental adhesive cream (corega ultra cream without flavor) cream (batch number dl1648, expiry date 31st october 2020) for adhesion.In (b)(6) 2018, the patient started corega ultra cream without flavor at an unknown dose twice daily.On an unknown date, an unknown time after starting corega ultra cream without flavor, 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), strength loss of (serious criteria other: serious per reporter), weight loss (serious criteria other: serious per reporter), feeling bad (serious criteria other: serious per reporter), accidental ingestion of product (serious criteria other: serious per reporter) and activities of daily living impaired.The action taken with corega ultra cream without flavor was unknown.On an unknown date, the outcome of the lung disorder, vomiting, sweating, anxiety, fever, burning in eyes, headache, strength loss of, weight loss, feeling bad, accidental ingestion of product and activities of daily living impaired were unknown.The reporter considered the lung disorder, vomiting, sweating, anxiety, fever, burning in eyes, headache, strength loss of, weight loss, feeling bad, accidental ingestion of product and activities of daily living impaired to be possibly related to corega ultra cream without flavor.Additional details: the patient had used corega ultra without flavor 19g, unknown formulation since (b)(6).She loved this product, but it caused too many harm in her life.She had started to feel bad 3 months ago.It caused a lung problem.She vomited a gooey and white thing.She sweated like a pig.It was a dangerous product, which caused her anxiety and fever.She was with 41 degrees, burning eyes and thought her head would break.She did not had strength to work.She lost 20kg of weight.The product was almost disabling her.She went to physician, but he informed that it was nothing.The physicians suspected that she had aids because she had all the symptoms that also seemed like hepatitis.Since she did not knew what she vomited, she took the vomit to the laboratory and they told her symptoms occurred due to the product.Product became "a drool" in her stomach.She could not imagine how many people must had died because of this product, because it did not appear in the blood count.She had to go to the laboratory and they told her that the "paste" caused all of the symptoms.The symptoms seemed symptoms of hepatitis.She had the symptoms of (b)(6) but the product was the causative of the symptoms.The consumer said that all these serious symptoms had happened with her because of the corega.She started crying during the phone call and she said that what was happening to her was because of the product.This case was linked to (b)(4) due to same reporter.

• Brand Name: COREGA ULTRA CREAM WITHOUT FLAVOR
• Type of Device: DENTURE ADHESIVE
• Manufacturer (Section D): GLAXOSMITHKLINE DUNGARVAN LTD; dungarvan,; waterford; EI
• Manufacturer Contact: po box 13398; research triangle park,; 8888255249
• MDR Report Key: 9291837
• MDR Text Key: 184884143
• Report Number: 3003721894-2019-00311
• 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
• Device Expiration Date: 10/31/2020
• Device Lot Number: DL1648
• Initial Date Manufacturer Received: 10/14/2019
• Initial Date FDA Received: 11/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/24/2018
• 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: 42 YR