inforMED
MalfunctionIWZ

SILMET

Received Jun 10, 2002

Report MW1025281 · MDR key 399292

Device

Generic name

Dental X-ray Film

Manufacturer

Silmet Usa

Model number

NI

Catalog number

NI

Lot number

NI

Product problems

  • Design/structure problem

Patient

NA

Narrative

Description of Event or Problem

ACCORDING TO RPTR SILMET USA SELLS A DANGEROUS PRODUCT. THE PRODUCT IS THEIR $17.95 BOX OF DENTAL X-RAY FILM FROM CHINA. THIS DENTAL X-RAY FILM HAS THE DIRECTIONAL INDICATOR DOT BACKWARDS FROM ALL OTHER FILM. RPTR HAS SEEN IN THE UNITED STATES SUCH AS THE INDUSTRY STANDARD BY KODAK, FLOW, AND AGFA. THE RESULT OF THIS FILM USE IS BACKWARD FILM PRESENTATIONS. THIS PROBLEM COULD BE MISSED BY THE USER CAUSING THE WRONG PT TOOTH TO BE TREATED. THIS PROBLEM COULD BE MISSED BY ANOTHER DR WHEN FILMS ARE ROUTINELY TRANSMITTED BETWEEN DRS RESULTING IN THE WRONG TOOTH TREATED. RPTR HAS COMPLAINED TO THE CO AS TO THE DANGER OF THIS FILM. TO THEIR KNOWLEDGE THEY ARE STILL SELLING THIS FILM WITH NO CORRECTIONS OR WARNINGS TO THE USER.