MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-04 for COREGA manufactured by Glaxosmithkline Dungarvan Ltd..
[23715909]
This report refers to an (b)(6) year old male consumer who used corega cream for about a year and a half. He stopped using the product about a year ago. According to the reporter (consumer's daughter), a hcp performs every morning a laryngeal aspiration and nebulizations in order to remove remaining cream in airways. On (b)(6) 2015, reporter informed that her father presented with a life-threatening seizure about a year ago and due to this she decided to stop using the adhesive cream. After this, her father presented with wheezing. She consulted with a otorhinolaryngologist who informed that the airways were congested and indicated aspirations and nebulizations. Reporter informed that the aspirated substance is white and gelatinous. The hcps consulted do not relate this to the use of the cream. Reporter also stated that corega was applied more than one time daily and in a large quantity (although this is not recommended in product label). An action taken for the device was unknown.
Patient Sequence No: 1, Text Type: N, H10
[23715910]
Seizure [seizure]. Wheezing [wheezing]. Maladministration [drug maladministration]. Case description: this case was reported by a consumer and described the occurrence of seizure in a (b)(6)-year-old female patient who received gsk denture adhesive (formulation unknown) (corega) cream for product used for unknown indication. The patient's past medical history included stroke and hip surgery (two years ago (unspecified). Concurrent medical conditions included senile dementia. On an unknown date, the patient started corega. On an unknown date, an unknown time after starting corega, the patient experienced seizure (serious criteria gsk medically significant and life threatening) and inappropriate schedule of drug administration. On an unknown date, the outcome of the seizure and inappropriate schedule of drug administration were unknown. It was unknown if the reporter considered the seizure to be related to corega.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003721894-2015-00003 |
| MDR Report Key | 4995094 |
| Date Received | 2015-08-04 |
| Date of Report | 2015-07-21 |
| Date Mfgr Received | 2015-07-21 |
| Date Added to Maude | 2015-08-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | PO BOX 13398 |
| Manufacturer City | RESEARCH TRIANGLE PARK NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 8888255249 |
| Manufacturer G1 | GSK |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | COREGA |
| Generic Name | DENTURE ADHESIVE |
| Product Code | KOL |
| Date Received | 2015-08-04 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GLAXOSMITHKLINE DUNGARVAN LTD. |
| Manufacturer Address | DUNGARVAN, WATERFORD EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Other | 2015-08-04 |