MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-11 for ADVANSYNC CROWNS manufactured by Ormco Corporation Inc..
[30988868]
A doctor alleged that the appliance cut into the cheeks of the patient and created an ulceration. The doctor cleaned the wound and did a laser treatment and added ointment. To date, the patient is doing fine.
Patient Sequence No: 1, Text Type: N, H10
[30988869]
A doctor alleged that a patient's advansync appliance caused by cutting into the cheeks of the patient and created an ulceration.
Patient Sequence No: 1, Text Type: D, B5
[36548391]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2016150-2015-00022 |
| MDR Report Key | 5218216 |
| Date Received | 2015-11-11 |
| Date of Report | 2015-10-20 |
| Date Mfgr Received | 2015-10-20 |
| Date Added to Maude | 2015-11-11 |
| 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 | MRS. SUZETTE RAMPAIR-JOHNSON |
| Manufacturer Street | 1332 SOUTH LONE HILL AVE. |
| Manufacturer City | GLENDORA CA 91740 |
| Manufacturer Country | US |
| Manufacturer Postal | 91740 |
| Manufacturer Phone | 9099625730 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVANSYNC CROWNS |
| Generic Name | ADVANSYNC CROWNS |
| Product Code | EBG |
| Date Received | 2015-11-11 |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORMCO CORPORATION INC. |
| Manufacturer Address | 1332 SOUTH LONE HILL AVE. GLENDORA CA 91740 US 91740 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-11-11 |