MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2007-03-14 for FACE BOW 300 SERIES 852-315 manufactured by American Orthodontics.
[15582253]
Orthodontic pt with ocular injury due to headgear. We are still unaware of all facts at this case recently came to litigation. Blindness in one eye; impaired vision in the other. The headgear, safety release modules and head strap no not appear to be defective. Preliminary info suggests instructions given.
Patient Sequence No: 1, Text Type: D, B5
[15945309]
By the orthodontist and improper removal of the headgear by the pt are significant factors in this injury.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2126683-2005-00002 |
| MDR Report Key | 2304440 |
| Report Source | 99 |
| Date Received | 2007-03-14 |
| Date of Report | 2005-10-27 |
| Date of Event | 2002-08-18 |
| Date Added to Maude | 2011-10-28 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FACE BOW |
| Generic Name | HEAD GEAR |
| Product Code | DZB |
| Date Received | 2007-03-14 |
| Model Number | 300 SERIES |
| Catalog Number | 852-315 |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMERICAN ORTHODONTICS |
| Manufacturer Address | 1714 CAMBRIDGE SHEBOYGAN WI 53081 US 53081 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Deathisabilit | 2007-03-14 |