MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-12-22 for ADVANSYNC manufactured by Ormco Corporation.
[2401140]
On (b)(6) 2011, a doctor alleged that a patient developed a cheek ulceration from wearing the advansync appliance. A fever and general malaise was also noted. On (b)(6) 2011, it was reported that the patient sought medical attention with her family physician and was prescribed antibiotics.
Patient Sequence No: 1, Text Type: D, B5
[9448734]
Treatment also included mouth rinses. To date, the patient has fully recovered and is doing fine. A new appliance with not be placed and re-fabrication of the original appliance will not be implemented because the patient has completed the course of treatment.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2016150-2011-00212 |
| MDR Report Key | 2386895 |
| Report Source | 05 |
| Date Received | 2011-12-22 |
| Date of Report | 2011-12-13 |
| Date Mfgr Received | 2011-11-23 |
| Date Added to Maude | 2011-12-22 |
| 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 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. ORLANDO TADEO, JR. |
| Manufacturer Street | 1717 W COLLINS AVE |
| Manufacturer City | ORANGE CA 92867 |
| Manufacturer Country | US |
| Manufacturer Postal | 92867 |
| Manufacturer Phone | 7145167419 |
| Manufacturer G1 | ORMCO CORPORATION |
| Manufacturer Street | 1332 SOUTH LONE HILL AVENUE |
| Manufacturer City | GLENDORA CA 91740 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 91740 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVANSYNC |
| Generic Name | BITE-JUMPING ORTHODONTIC APPLIANCE |
| Product Code | EJF |
| Date Received | 2011-12-22 |
| ID Number | WORK ORDER #3361874 |
| Operator | DENTIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORMCO CORPORATION |
| Manufacturer Address | 1332 SOUTH LONE HILL AVENUE GLENDORA CA 91740 US 91740 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2011-12-22 |