MAUDE Adverse Event Report: GLAXOSMITHKLINE COREGA DENTURE ADHESIVE CREAM; GSK DENTURE ADHESIVE (FORMULATION UNK)

Device Problem Insufficient Information (3190)

Patient Problems Paralysis (1997); Paraplegia (2448)

Event Type  Other  

Event Description

This case was reported by a consumer's neighbor (who is a distributor) and described the occurrence of hemiplegia in a (b)(6) year-old female patient who received gsk denture adhesive (formulation unk) (corega denture adhesive cream) for dentures.A physician or other health care professional has not verified this report.On an unk date, the patient started gsk denture adhesive (formulation unk) (dental).At an unk time after starting gsk denture adhesive (formulation unk), the patient experienced hemiplegia and facial paralysis.The patient's neighbor reported that the patient was hospitalized due to hemiplegia and facial paralysis (unk cause).The patient was hospitalized.At the time of reporting, the events were unresolved.The reporter considered the event to be not related to treatment with corega denture adhesive cream.

Manufacturer Narrative

Gsk denture adhesive (corega denture adhesive cream) is manufactured in (b)(4).The product and lot number for this product are not available.(b)(4).

• Brand Name: COREGA DENTURE ADHESIVE CREAM
• Type of Device: GSK DENTURE ADHESIVE (FORMULATION UNK)
• Manufacturer (Section D): GLAXOSMITHKLINE; research triangle park NC 27709
• Manufacturer (Section G): GLAXOSMITHKLINE; youghal rd.; clocherane; dungarvan co., waterford ; EI
• Manufacturer Contact: po box 13398; research triangle park, NC 27709 ; 8888255249
• MDR Report Key: 4121403
• MDR Text Key: 19719678
• Report Number: 9681138-2014-00023
• Device Sequence Number: 1
• Product Code: KOL
• Combination Product (y/n): N
• Reporter Country Code: PE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 09/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/19/2014
• 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): Hospitalization
• Patient Age: 58 YR