MAUDE Adverse Event Report: GLAXOSMITHKLINE COREGA (UNSPECIFIED DENTURE ADHESIVE OR DENTURE CLEANSER); UNKNOWN

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

Patient Problem Meningitis (2389)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Toxic poisoning [drug toxicity].The whole skin burns [burning skin].The mucous membrane is gone [mucous membrane disorder].Extreme headache [headache].Lead deposit in the body [lead poisoning].Meningitis [meningitis].Rapid heartbeat [heartbeats increased].Case description: this retrospective pregnancy case was reported by a consumer via call center representative and described the occurrence of drug toxicity in a (b)(6)-year-old female patient who received corega (corega (unspecified denture adhesive or denture cleanser)) unknown for skin induration.On (b)(6) 2015, the patient started corega (unspecified denture adhesive or denture cleanser).The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date.On (b)(6) 2019, 4 years and 296 days after starting corega (unspecified denture adhesive or denture cleanser), the patient experienced drug toxicity (serious criteria gsk medically significant and life threatening), burning skin, mucous membrane disorder, headache, lead poisoning (serious criteria gsk medically significant), meningitis (serious criteria gsk medically significant), heartbeats increased, drug exposure during pregnancy and unintentional use for unapproved indication, live birth.The action taken with corega (unspecified denture adhesive or denture cleanser) was unknown.On an unknown date, the outcome of the drug toxicity, burning skin, mucous membrane disorder, headache, lead poisoning, meningitis, heartbeats increased, drug exposure during pregnancy and unintentional use for unapproved indication,live birth were unknown.The pregnancy resulted in a live neonate with a congenital anomaly.It was unknown if the reporter considered the drug toxicity, burning skin, mucous membrane disorder, headache, lead poisoning, meningitis and heartbeats increased to be related to corega (unspecified denture adhesive or denture cleanser).Additional details: initial and follow up was processed together.The patient mother had reported that she had used product against hard skin to become softened her feet and hands and now she know that this was a wrong application, but she was advised to do so back then since that time she had been suffering from poisoning and had various side effects.She became pregnant during this time of incorrect use of the product and her child has also suffered from various side effects since birth.The child was even taken away from me and taken to a home.The patient mother had reported that her child was whole skin burns, mucous membrane was gone, extreme headache, lead deposit in the body, meningitis, rapid heartbeat.This case was linked with (b)(4) by same reporter (child case).Follow up received on 24 oct 2019, no information was provided.

• Brand Name: COREGA (UNSPECIFIED DENTURE ADHESIVE OR DENTURE CLEANSER)
• Type of Device: UNKNOWN
• Manufacturer (Section D): GLAXOSMITHKLINE; dungarvan ltd; dungarvan,; waterford, ; EI
• Manufacturer Contact: po box 13398; research triangle park; 8888255249
• MDR Report Key: 9329034
• MDR Text Key: 166666013
• Report Number: 3003721894-2019-00319
• Device Sequence Number: 1
• Product Code: KOT
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Initial Date Manufacturer Received: 10/22/2019
• Initial Date FDA Received: 11/15/2019
• 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): Life Threatening; Other
• Patient Age: 46 YR