MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2015-06-26 for COREGA manufactured by Glaxosmithkline Dungarvan Ltd.
[6057709]
Anaphylaxis. Swollen lips, terrible sore throat, bleeding gums, swollen upper, breathlessness, hoarse voice, product complaint. Case description: this case was reported by a physician and described the occurrence of anaphylaxis in a female patient who received gsk denture adhesive (formulation unknown) (corega) cream for drug use for unknown indication. On an unknown date, the patient started corega. On an unknown date, an unknown time after starting corega, the patient experienced anaphylaxis (serious criteria gsk medically significant and clinically significant/intervention required), lip swelling, sore throat, gingival bleeding, swelling, breathlessness and hoarse voice. On an unknown date, the outcome of the anaphylaxis, lip swelling, sore throat, gingival bleeding, swelling, breathlessness and hoarse voice were unknown. It was unknown if the reporter considered the anaphylaxis, lip swelling, sore throat, gingival bleeding, swelling, breathlessness and hoarse voice to be related to corega. This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details: this is an initial report of a spontaneous adverse event corega cream in a female consumer who is also a health care professional, with initials cbt. She reported this occurrence to the gsk call center. She has reported that for a long time she used the corega powder however due to current stock-outs in the local market she started using corega cream (dates not specified). She reported that she experienced anaphylaxis, with the following events: swollen lips, a swollen upper palate, breathlessness, bleeding gums, terrible sore throat and a hoarse voice. The lot number for the product is v14081. Follow-up was conducted and this is all the information that was gathered from the reporter. Follow up information received on 12 february 2015: qa analysis revealed the complaint to be unsubstantiated.
Patient Sequence No: 1, Text Type: D, B5
[13700147]
The complaint sample was sent to the lab for analysis. Test: description specification: a reddish pink mass of gums and petrolatum, free of lumps, granular particles or foreign matter. Result: complies. Test: ph. Specification: 6. 5 to 7. 5. Result: 6. 5. Testing was carried out on the complaint sample and results were within specification indicating that the product was satisfactory for use. The batch documentation was checked before release and also on receipt of this complaint and found to be satisfactory. See scanned page.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9681138-2015-00035 |
| MDR Report Key | 4877677 |
| Report Source | 01,05 |
| Date Received | 2015-06-26 |
| Date of Report | 2015-01-22 |
| Date Mfgr Received | 2015-01-22 |
| Date Added to Maude | 2015-07-06 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | P.O 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 | 3 |
| Brand Name | COREGA |
| Generic Name | DENTURE ADHESIVE |
| Product Code | KOL |
| Date Received | 2015-06-26 |
| Lot Number | V14081 |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GLAXOSMITHKLINE DUNGARVAN LTD |
| Manufacturer Address | DUNGARVAN EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2015-06-26 |