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

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

Patient Problem Cataract (1766)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Cataract [cataract]; allergy [allergy]; eye surgery [eye operation]; sick of the stomach [upset stomach].Case description: this case was reported by a consumer via call center representative and described the occurrence of cataract in a (b)(6) year-old female patient who received double salt dental adhesive cream (ultra corega flavor free) cream for dental prosthesis user.On an unknown date, the patient started ultra corega flavor free.On an unknown date, an unknown time after starting ultra corega flavor free, the patient experienced cataract (serious criteria gsk medically significant), allergy, eye operation and upset stomach.The action taken with ultra corega flavor free was unknown.On an unknown date, the outcome of the cataract, allergy, eye operation and upset stomach were unknown.It was unknown if the reporter considered the cataract, allergy, eye operation and upset stomach to be related to ultra corega flavor free.Additional details: patient was using corega, however, it was causing allergy.She could not stay with it and she had to get it off.It also made her sick of the stomach.The patient informed she could not see the expiration date of the product because she had cataract in one eye and on the other one she had undergone a surgery (unspecified).

• Brand Name: ULTRA COREGA FLAVOR FREE
• 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: 8775330
• MDR Text Key: 150539117
• Report Number: 3003721894-2019-00178
• 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: 06/26/2019

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: Health Professional
• Initial Date Manufacturer Received: 06/26/2019
• Initial Date FDA Received: 07/10/2019
• 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: 66 YR