MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2020-01-07 for COREGA DENTURE ADHESIVE FORMULATION UNKNOWN manufactured by Glaxosmithkline Dungarvan Ltd.
[177242481]
Argus case (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[177242482]
It damaged her liver [hepatic damage]. Case description: this case was reported by a consumer via interactive digital media ((b)(6)) and described the occurrence of hepatic damage in a female patient who received gsk denture adhesive (formulation unknown) (corega denture adhesive formulation unknown) unknown (batch number unk, expiry date unknown) for product used for unknown indication. This case was associated with a product complaint. On an unknown date, the patient started corega denture adhesive formulation unknown at an unknown dose and frequency. On an unknown date, an unknown time after starting corega denture adhesive formulation unknown, the patient experienced hepatic damage (serious criteria gsk medically significant) and product complaint. The action taken with corega denture adhesive formulation unknown was unknown. On an unknown date, the outcome of the hepatic damage and product complaint were unknown. It was unknown if the reporter considered the hepatic damage to be related to corega denture adhesive formulation unknown. Additional details: initial and follow up processed together. Consumer informed that it did not stick, she also said that it damaged her liver. Follow up received on 13 dec 2019: no new medically significant information reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003721894-2019-00382 |
| MDR Report Key | 9557894 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2020-01-07 |
| Date of Report | 2019-12-12 |
| Date Mfgr Received | 2019-12-12 |
| Date Added to Maude | 2020-01-07 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | PO BOX 13398 RESEARCH TRIANGLE PARK |
| Manufacturer City | NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 8888255249 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COREGA DENTURE ADHESIVE FORMULATION UNKNOWN |
| Generic Name | DENTURE ADHESIVE |
| Product Code | KOT |
| Date Received | 2020-01-07 |
| 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. Other | 2020-01-07 |