DETREY CONDITIONER 36
Received Aug 7, 2008 · Event occurred Apr 21, 2009
Report 8010638-2009-00108 · MDR key 1435846
Device
Product problems
- Burst Container or Vessel
Patient
UNK
- Visual Impairment
- Eye Burn
- Caustic/Chemical Burns
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING A PROCEDURE, A SYRINGE OF DETREY CONDITIONER 36 BURST, CAUSING THE MATERIAL TO CONTACT THE PATIENT'S FACE AND RIGHT EYE, RESULTING IN A CHEMICAL BURN TO THE CORNEA AND FORNIX CONJUNCTIVAE INFERIOR. THE PATIENT WAS TREATED AT A HOSPITAL FOR SIX DAYS AND AS OF THE REPORT HAD IMPAIRED VISUAL PERFORMANCE; 30% WITHOUT GLASSES, 80% WITH GLASSES.
Additional Manufacturer Narrative
WHILE THERE IS NO INDICATION THAT THE DEVICE INVOLVED MALFUNCTIONED IN THIS CASE, THIS EVENT RESULTED IN A SERIOUS INJURY. FURTHER, THOUGH THE DEVICE INVOLVED IS NOT SOLD IN THE US, IT IS CONSIDERED SIMILAR TO DEVICES THAT ARE BASED ON ITS COMPOSITION AND SYRINGE DELIVERY MECHANISM. THEREFORE, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803.