inforMED
KMT

SULTAN

Received Oct 10, 2002

Report MW1026397 · MDR key 421033

Device

Generic name

Double Fluoride Tray

Manufacturer

Sultan

Model number

*

Catalog number

*

Lot number

*

Product problems

  • Reaction

Patient

UNKNOWN

  • Death
  • Vomiting
  • Other (for use when an appropriate patient code cannot be identified)
  • Choking

Narrative

Description of Event or Problem

WHEN THESE TRAYS ARE USED FOR YOUNG CHILDREN THEY TEND TO CHOKE, GAG, AND VOMIT. THERE HAVE BEEN 2 PTS (PEDIATRIC) WHO DIED AFTER THEY USED THE DEVICE. RPTR WILL NOT USE THESE DEVICES ON PTS. RPTR FEELS THAT THEY SHOULD BE OUTLAWED FOR CHILDREN. THEY CHOKE, GAG, AND VOMIT WHEN USING THESE DEVICES.