MalfunctionKKO

FIRST YEARS TEETHER

Received May 10, 2006 · Event occurred Sep 1, 2005

Report MW1039118 · MDR key 722848

Device

Generic name

Manufacturer

Model number

Catalog number

Lot number

Product problems

Nonstandard Device
Microbial Contamination of Device

Patient

10 MO

Therapy/non-surgical treatment, additional

Narrative

Description of Event or Problem

MY SON INGESTED THE BACTERIA IN THE FIRST YEARS TEETHER THAT WAS RECALLED. HE HAS UNDERGONE 2 PROCEDURES AND MORE WILL GO ON THIS WEEK. I CONTACTED THE CO AND THEY ARE STILL NOT REPORTING ANY SERIOUS ILLNESS. THERE HAVE BEEN LEAKING REPORTS, BITE THROUGH, AND CUTS. MY SON IS STILL SERIOUSLY ILL. PLEASE HELP ME HELP OTHER PARENTS REGARDING THE SERIOUS REACTIONS OF THIS BACTERIA THAT MY SON INGESTED. THE CO HAS NOT BEEN FORTHRIGHT WITH US TO DATE.