BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2416455-1999-00003

    MDR report key: 257279 · Received December 30, 1999

    Report

    Report Number
    2416455-1999-00003
    Event Type
    Injury
    Date Received
    December 30, 1999
    Date of Event
    December 7, 1999
    Report Date
    December 30, 1999
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    DR CALLED AND REPORTED OF HAVING BEEN PRACTICING DENTISTRY FOR SEVENTEEN YEARS; THAT DR USES ENDO ICE FOR DIAGNOSTIC TESTING OF TEETH (TO DETERMINE TOOTH VITALITY) AND ALSO TO TREAT MUSCLE SPASMS BY SPRAYING THE COLD MATERIAL TO THE AFFECTED AREA; THIS SORT OF SHOCKS THE SPASM AND IT STOPS. DR REPORTED THAT, ON 7 DECEMBER 1999, DR USED THIS PROCESS WITH ENDO ICE (BATCH NO. G109-9909-1401) ON A PT, GENERALLY IN GOOD HEALTH. ACCORDING TO THE DR, THIS TREATMENT UNFORTUNATELY RESULTED IN THE PT RECEIVING AN APPARENTLY SEVERE FROST BITE ON THE CHEEK. AT THE TIME OF THE SUBJECT TELCON, DR WAS CONCERNED WITH THE HEALING OF THIS FROST BITE AND RECOMMENDED THAT THE PT SEE A PLASTIC SURGEON. WHEN CO REP ASKED IF THE DR THOUGHT THAT THERE MIGHT BE ANYTHING WRONG WITH THE CAN/CONTAINER, HE INDICATED THAT THERE WAS NOTHING WRONG WITH THE CAN AND THAT DR'S ONLY REASON FOR CALLING WAS NOT TO FAULT ANYONE, BUT TO POINT OUT TO THE CO, COLTENE/WHALEDENT INC., THAT CO SHOULD CONSIDER TO MAKE THE CAUTION NOTICE MORE PROMINENT.

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other