inforMED
MalfunctionEAY

QHL75CURING LIGHT

Received May 14, 2001 · Event occurred Mar 10, 2001

Report 2515379-2001-00004 · MDR key 333296

Device

Generic name

Dental Curing Light

Manufacturer

L.d. Caulk

Model number

506

Catalog number

644656

Lot number

NA

Product problems

  • Detachment Of Device Component
  • Component Falling
  • Unintended Collision

Patient

37 YR

  • Dural Tear
  • Bleeding
  • Therapy/non-surgical treatment, additional

Narrative

Description of Event or Problem

WHEN THE DENTIST REMOVED THE LIGHT FROM CURING A COMPOSITE ON AN UPPER ARCH TOOTH, THE NOSE CONE FELL OFF AND HIT THE PATIENT'S NOSE LEAVING A 12MM LONG CUT ABOUT 2MM DEEP. THE DENTIST WAS ABLE TO CONTROL THE BLEEDING BY APPLYING DIRECT PRESSURE. ACCORDING TO THE DENTIST NO GLASS OR DEBRIS ENTERED THE EYE.