MAUDE Adverse Event Report: GLAXOSMITHKLINE DUNGARVAN LTD COREGA DENTURE ADHESIVE CREAM

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

Patient Problem Obstruction/Occlusion (2422)

Event Type  Injury  

Manufacturer Narrative

Argus case (b)(4).

Event Description

Gastrointestinal obstruction [gastrointestinal obstruction].Continuous stomachache [stomach pain].Suspicion of abnormal colon mass [intestinal mass].Case description: this case was reported by a consumer via sales rep and described the occurrence of gastrointestinal obstruction in a (b)(6) old male patient who received double salt dental adhesive cream (corega denture adhesive cream) cream for denture wearer(denture fixation).On an unknown date, the patient started corega denture adhesive cream at an unknown dose and frequency.On an unknown date, an unknown time after starting corega denture adhesive cream, the patient experienced gastrointestinal obstruction (serious criteria gsk medically significant), stomach pain, intestinal mass and accidental ingestion of product.The action taken with corega denture adhesive cream was unknown.On an unknown date, the outcome of the gastrointestinal obstruction, stomach pain, intestinal mass and accidental ingestion of product were unknown.It was unknown if the reporter considered the gastrointestinal obstruction, stomach pain, intestinal mass and accidental ingestion of product of product to corega denture adhesive cream.Additional information: initial and follow up processed together.The patient reported that he had a serious problem.He had been using your corega denture cream (different types) for several years.He did not pay attention so far but he simply used to swallow some of the glue because he had 2 dentures and he used it really a lot.Some 2 months ago he had gastrointestinal obstruction.He had a continuous stomachache and the tests revealed suspicion of abnormal colon mass.He would be grateful for an answer whether you ever had a similar case before and what is (if there was) a way to break through this mass that developed in the lower portion of his gastrointestinal tract and would lead to very serious complications.Follow up was received on 31 jul 2019: on an unknown date, 91 days after starting corega denture adhesive cream, the patient experienced gastrointestinal obstruction (serious criteria gsk medically significant), stomach pain, intestinal mass and accidental ingestion of product.Patients demographics was updated.

• Brand Name: COREGA DENTURE ADHESIVE CREAM
• 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: 9925687
• MDR Text Key: 195278280
• Report Number: 3003721894-2019-00228
• 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
• Report Date: 07/30/2019

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: 07/30/2019
• Initial Date FDA Received: 04/03/2020
• 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: 63 YR