inforMED
MalfunctionIWZ

DF 57C DENTAL X-RAY FILM

Received Sep 22, 2004 · Event occurred Sep 21, 2004

Report MW1033299 · MDR key 558326

Device

Generic name

Dental X-ray Film

Manufacturer

Eastman Kodak

Catalog number

*

Lot number

*

Product problems

  • Design/structure problem
  • Image Resolution Poor
  • Tear, Rip or Hole in Device Packaging

Patient

62 YR

  • Unknown (for use when the patient's condition is not known)

Narrative

Description of Event or Problem

KODAK DF57C DENTAL INTRAORAL X-RAY FILM HAS SOME FILMS ENCLOSED IN A DEFECTIVE LIGHT PROOF COVER. THEY HAVE A SMALL SLIT IN THE SIDE OF THE COVER WHICH ALLOWS LIGHT ENTRANCE, RESULTING IN BLACKING OUT OF PART OF THE IMAGE.