inforMED
MalfunctionIWZ

KODAK ULTRA-SPEED

Received Nov 9, 2005 · Event occurred Oct 24, 2005

Report MW1037136 · MDR key 746931

Device

Generic name

Dental X-ray Film

Manufacturer

*

Model number

*

Catalog number

*

Lot number

*

Product problems

  • Material Discolored

Patient

*

  • Therapy/non-surgical treatment, additional

Narrative

Description of Event or Problem

DENATL X-RAY FILM IS DEFECTIVE. KODAK ULTRASPEED DF-58 SIZE 2, MADE IN FRANCE. THE IMAGE DEVELOPS A MOTH EATEN APPEARANCE SHORTLY AFTER DEVELOPED. BEFORE RPTR KNEW IT WAS THE FILM RPTR WAS CHANGING THE SOLUTIONS, REINSTRUCTING THE ASSISTANTS. BECAUSE OF THE PROBLEM, RPTR HAD TO RETAKE SEVERAL X-RAYS. RPTR IS UPSET KODAK DID NOT SEND A RECALL NOTICE TO SUPPLIER.