BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DENTUREID

    MDR report key: 8492299 · Received April 8, 2019

    Report

    Report Number
    1315551-2019-00001
    Event Type
    Injury
    Date Received
    April 8, 2019
    Report Date
    March 1, 2019
    Manufacturer
    CMP INDUSTRIES LLC
    Product Code
    PYQ
    PMA / PMN Number
    K170423
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON JANUARY 23, 2019 I RECEIVED AN EMAIL FROM CUSTOMER SERVICE FORWARDING AN INQUIRY FROM THE WEBSITE. THE EMAIL WAS FROM (B)(6) OF (B)(6) DENTAL ARTS ((B)(6)) REQUESTING THAT HE SEND BACK 7 MICROCHIPS FOR REIMBURSEMENT. HE STATED THAT A PATIENT HAD A REACTION TO THE RADIO FREQUENCY OR SOMETHING IN THE DENTUREID AND HAD TO GO TO THE ER. I CONTACTED (B)(6) DENTAL ARTS AND SPOKE TO (B)(6). (B)(6) TOLD ME THAT THE DENTUREID WAS REMOVED FROM THE PATIENT APPLIANCE AND WAS NOT AVAILABLE FOR RETURN SINCE THE LAB DISPOSED OF DENTUREID. THE APPLIANCE WAS THEN RETURNED TO THE PATIENT FOR USAGE. I REQUESTED INFORMATION ON WHAT WAS USED TO FABRICATE THE APPLIANCE AND THE MATERIAL USED TO EMBED THE DENTUREID ON FEBRUARY 1, 5, 8, 18, 19 AND 28, 2019. I DID NOT GET A DEFINITIVE ANSWER AT THIS TIME. I REQUESTED PATIENT INFORMATION AND WHAT MATERIALS WERE USED TO FABRICATE THE DENTAL APPLIANCE THAT WERE ALSO USED WITH THE DENTUREID MICROCHIP. AT THIS TIME, (B)(6) HAS NOT RETURNED MY REQUEST FOR INFORMATION. RECEIVED PRODUCTION ACCOUNT ON 4/4/19.

    Description of Event or Problem · 1

    DENTAL LAB REPORTED THAT A PATIENT HAD A REACTION TO DENTUREID AND HAD TO GO THE ER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286586 DENTUREID RFID CHIP FOR DENTAL APPLIANCE PYQ CMP INDUSTRIES LLC D1EN 5104

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization UNKNOWN DENTURE BASE MATERIAL.