AIREL IGN 500
Received Jan 13, 1994
Report MW1000486 · MDR key 11051
Device
Manufacturer
AirelProduct problems
- False claim
Patient
*
Narrative
Description of Event or Problem
THE DEVICE IS A NEW PRODUCT TO THE DENTAL MARKET THAT CLAIMS TO PRODUCE "ASEPTICALLY PURE" WATER IN THE DENTAL UNIT. IT USES A SOLUTION CALLED CALBENIUM AS A BACTERIOSTATIC, BACTERIOCIDAL AND VIRUCIDAL AGENT THAT IS EFFECTIVE FOR 100 DAYS. THE LITERATURE FROM THE MFR SUGGESTS THE DENTAL UNIT WILL PRODUCE A STERILE SPRAY IF THE DEVICE IS USED WHICH IS SUITABLE FOR SURGERY. ACCORDING TO THE JADA, 10/93, AS WELL AS OTHER PUBLICATIONS DENTAL UNIT WATERLINES ARE HIGHLY CONTAMINATED WITH BACTERIA DUE TO THE PRESENCE OF A BIOFILM LINING THE TUBINGS. A DISINFECTANT SOLUTION WOULD NEED TO BE EXTREMELY POTENT TO REMOVE ALL BACTERIA FROM THE BIOFILM, AND IF THIS IS TRUE THE SOLUTION LIKELY WOULD PROVE TOXIC TO PTS. RPTR QUESTIONS IF THIS CALBENIUM SOLUTION HAS BEEN PROVEN NON-TOXIC AND HAS IT BEEN SHOWN TO REMOVE BIOFILM.