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

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

Patient Problems Vomiting (2144); Obstruction/Occlusion (2422); Patient Problem/Medical Problem (2688); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Mfr report is associated with argus case (b)(4), corega denture adhesive cream.Corega denture adhesive cream is marketed as super poligrip in the us.

Event Description

Intestinal neoplasm [gastrointestinal neoplasm].Intestinal obstruction [intestinal obstruction].Vomiting [vomiting].Ability to eat only liquid food [eating disorder].Inappropriate frequency of use [inappropriate schedule of drug administration].Swallowed some cream [accidental ingestion of drug].Case description: this case was reported by a dentist via call center representative and described the occurrence of gastrointestinal neoplasm in a (b)(6) female patient who received double salt dental adhesive cream (corega denture adhesive cream) cream for denture wearer.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 neoplasm, intestinal obstruction (serious criteria gsk medically significant), vomiting, eating disorder, accidental ingestion of drug and inappropriate schedule of drug administration.Corega denture adhesive cream was discontinued (dechallenge was positive).On an unknown date, the outcome of the gastrointestinal neoplasm, intestinal obstruction and eating disorder were recovered/resolved and the outcome of the vomiting and inappropriate schedule of drug administration were not reported and the outcome of the accidental ingestion of drug was unknown.It was unknown if the reporter considered the gastrointestinal neoplasm, intestinal obstruction, vomiting and eating disorder to be related to corega denture adhesive cream.Additional details: the patient used corega denture adhesive cream several times a day for denture fixation.Every using the consumer swallowed some cream and after several years of used she experienced intestinal neoplasm.Because of this intestinal neoplasm the consumer experienced intestinal obstruction, vomiting, ability to eat only liquid food.The consumer thought she was dying.Also, it was reported the intestinal obstruction was so heavy that it was impossible to provide colonoscopy.The dentist reported that the patient's health was well, she had not problems with stomach and intestinal.

• 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, NC 27709 ; 8888255249
• MDR Report Key: 8301686
• MDR Text Key: 135151348
• Report Number: 3003721894-2019-00028
• 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: foreign,health professional
• Type of Report: Initial
• Report Date: 01/25/2019

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: 01/25/2019
• Initial Date FDA Received: 02/04/2019
• 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: 60 YR