MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-11-08 for FACE BOW 300 SERIES 852-315 manufactured by American Orthodontics.
[17369043]
Orthodontic patient with ocular injury due to headgear - we are still unaware of all facts as this case recently came to litigation. Blindness in one eye and impaired vision in the other. The headgear does not appear to be defective nor do the safety release modules or head strap. Preliminary information suggests instructions from the dr. And improper removal of the headgear by the patient are significant factors in this injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2126683-2005-00001 |
| MDR Report Key | 972999 |
| Date Received | 2005-11-08 |
| Date of Report | 2005-01-27 |
| Date of Event | 2002-08-18 |
| Date Added to Maude | 2008-01-15 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 1714 CAMBRIDGE AVE. |
| Manufacturer City | SHEBOYGAN WI 53081 |
| Manufacturer Country | US |
| Manufacturer Postal | 53081 |
| Manufacturer G1 | AMERICAN ORTHODONTICS |
| Manufacturer Street | 1714 CAMBRIDGE AVE. |
| Manufacturer City | SHEBOYGAN WI 53081 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53081 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FACE BOW |
| Generic Name | HEAD GEAR |
| Product Code | DZB |
| Date Received | 2005-11-08 |
| Model Number | 300 SERIES |
| Catalog Number | 852-315 |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 942876 |
| Manufacturer | AMERICAN ORTHODONTICS |
| Manufacturer Address | 1714 CAMBRIDGE SHEBOYGAN WI 53081 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Deathisabilit | 2005-11-08 |