MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-06-01 for ALIKE 4OZ LIQUID 340591 manufactured by Gc America Inc..
[76450029]
Should additional relevant information become available, a supplemental report will be submitted. Unable to reach patient or dentist.
Patient Sequence No: 1, Text Type: N, H10
[76450030]
Gc america inc. (gca) received a letter from a patient on 17 mar 2017. The patient had received dental work in a university setting by a dental provider on 07 mar 2017. The patient's mouth began to burn. The dental provider had used the following chemicals: viscostat, henry schein temporary cement remover, vps tray adhesive, and alike liquid monomer. The dental provider put vaseline on the patient's burned lips and gave the patient vaseline to continue putting on their mouth. On (b)(6) 2017, the patient had an appointment with their personal doctor to examine the burns and to check their high blood pressure. The personal doctor prescribed cephalexin to prevent an infection from the burns and silver sulfadiazine to avoid or treat skin infections from the burns. No additional information was obtained.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1410097-2017-00001 |
| MDR Report Key | 6605730 |
| Report Source | CONSUMER |
| Date Received | 2017-06-01 |
| Date of Report | 2017-06-01 |
| Date of Event | 2017-03-07 |
| Date Mfgr Received | 2017-03-17 |
| 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 | ALIKE 4OZ LIQUID |
| Generic Name | TEMPORARY CROWN AND BRIDGE RESIN |
| Product Code | EBG |
| Date Received | 2017-06-01 |
| Catalog Number | 340591 |
| Operator | DENTIST |
| 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. Other | 2017-06-01 |