MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-06 for FACEBOW 200-0221 manufactured by Ormco Corporation.
[91185802]
It was alleged that a patient had an allergic reaction to the facebow; however no further specific information has been received at this time. Attempts are being made to get further information and will an update.
Patient Sequence No: 1, Text Type: N, H10
[91185803]
It was alleged that a patient had an allergic reaction to facebow.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2016150-2017-00005 |
| MDR Report Key | 7005152 |
| Date Received | 2017-11-06 |
| Date of Report | 2017-10-23 |
| Date of Event | 2017-10-23 |
| Date Mfgr Received | 2017-10-23 |
| Date Added to Maude | 2017-11-06 |
| 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 |
| Reporter Occupation | SERVICE PERSONNEL |
| 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 |
| Manufacturer G1 | ORMEX S. DE R.L. DE C.V. |
| Manufacturer Street | CALLE 21 NO 1103 AMP CD INDUSTRIAL |
| Manufacturer City | UMAN, YUCATAN CA 97390 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 97390 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | FACEBOW |
| Generic Name | FACEBOW |
| Product Code | DZB |
| Date Received | 2017-11-06 |
| Returned To Mfg | 2017-11-09 |
| Catalog Number | 200-0221 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORMCO CORPORATION |
| Manufacturer Address | 1332 SOUTH LONE HILL AVE. GLENDORA CA 91740 US 91740 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-11-06 |