MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2017-06-01 for COE-SOFT 5.5 OZ PROFESSIONAL PACKAGE 344011 manufactured by Gc America Inc..
[76447272]
Should additional relevant information become available, a supplemental report will be submitted. Not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[76447273]
Gc america inc. (gca) received report mw5068722 from fda's medwatch program on 20 apr 2017. The patient was present at a dental office and under the care of a female dentist. When at or shortly after 3 pm, the dentist applied a dental product known as the brand-name "coe-soft" used as a temporary denture liner. The patient experienced the following symptoms: sinus inflammation, adrenaline rush, fast heart rate (pounding heart), throat scratchiness and stiffness with difficulty swallowing, tightness in the chest, and inability to take a full breath. The patient instructed the dentist to call 911 for the allergic reaction. 'name withheld' responded because an ambulance was not close enough. The ambulance arrived and transported the patient to a hospital where treatment was started and completed with 50 mg of benadryl by mouth, 40 mg of prednisone by mouth, 10 mg of famotidine by mouth. Symptoms took 4 to 4. 5 hours to subside once treatment was started. No additional information was obtained.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1410097-2017-00002 |
| MDR Report Key | 6605335 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2017-06-01 |
| Date of Report | 2017-06-01 |
| Date of Event | 2017-03-27 |
| Date Mfgr Received | 2017-04-20 |
| Date Added to Maude | 2017-06-01 |
| 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 Contact | DR. MARK HEISS |
| Manufacturer Street | 3737 W. 127TH ST. |
| Manufacturer City | ALSIP IL 60803 |
| Manufacturer Country | US |
| Manufacturer Postal | 60803 |
| Manufacturer Phone | 7089263090 |
| Manufacturer G1 | GC AMERICA INC. |
| Manufacturer Street | 3737 W. 127TH ST. |
| Manufacturer City | ALSIP IL 60803 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60803 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COE-SOFT 5.5 OZ PROFESSIONAL PACKAGE |
| Generic Name | DENTURE RELINE |
| Product Code | EBI |
| Date Received | 2017-06-01 |
| Catalog Number | 344011 |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GC AMERICA INC. |
| Manufacturer Address | 3737 W. 127TH ST. ALSIP IL 60803 US 60803 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2017-06-01 |