FACE BOW
Received Nov 8, 2005 · Event occurred Aug 18, 2002
Report 2126683-2005-00001 · MDR key 972999
Device
Generic name
Head Gear
Manufacturer
American OrthodonticsModel number
300 SERIESCatalog number
852-315
Lot number
NA
Product problems
- Use of Device Problem
Patient
12 YR
- Blindness
- Eye Injury
- Visual Impairment
- Hospitalization required
Narrative
Description of Event or Problem
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.