InjuryDZB
FACE BOW
Received Mar 14, 2007 · Event occurred Aug 18, 2002
Report 2126683-2005-00002 · MDR key 2304440
Device
Generic name
Head Gear
Manufacturer
American OrthodonticsModel number
300 SERIESCatalog number
852-315
Lot number
NA
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
12 YR
- Visual Impairment
- Loss of Vision
Narrative
Additional Manufacturer Narrative
BY THE ORTHODONTIST AND IMPROPER REMOVAL OF THE HEADGEAR BY THE PT ARE SIGNIFICANT FACTORS IN THIS INJURY.
Description of Event or Problem
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.