BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETM FLUSH CUT DISTAL-END CUTTER WITH SAFETY HOLD

    MDR report key: 6159692 · Received December 9, 2016

    Report

    Report Number
    2016150-2016-00007
    Event Type
    Injury
    Date Received
    December 9, 2016
    Report Date
    November 15, 2016
    Manufacturer
    ORMCO CORPORATION
    Product Code
    EKD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS ALLEGED THAT A PATIENT WAS SENT TO AN ORAL SURGEON AND SURGICAL INTERVENTION MAY HAVE BEEN REQUIRED; HOWEVER NO FURTHER SPECIFIC INFORMATION HAS BEEN RECEIVED. MULTIPLE ATTEMPTS WERE MADE TO CONTACT THE COMPLAINANT ON 11/15/2016, 11/16/2016, 11/30/2016, AND 12/05/2016 IN ORDER TO OBTAIN FURTHER INFORMATION; HOWEVER, THE COMPLAINANT HAS REMAINED UNRESPONSIVE. NO FURTHER INFORMATION HAS BEEN RECEIVED TO SUGGEST THAT A SERIOUS INJURY WAS ASSOCIATED WITH THIS INCIDENT.

    Additional Manufacturer Narrative · 1

    IT WAS ALLEGED THAT A PATIENT WAS SENT TO AN ORAL SURGEON AND SURGICAL INTERVENTION MAY HAVE BEEN REQUIRED; HOWEVER NO FURTHER SPECIFIC INFORMATION HAS BEEN RECEIVED AT THIS TIME. AN UPDATE WILL BE PROVIDED UPON RECEIPT OF NEW INFORMATION.

    Description of Event or Problem · 1

    IT WAS ALLEGED THAT A PATIENT WAS SENT TO AN ORAL SURGEON AND SURGICAL INTERVENTION MAY HAVE BEEN REQUIRED; HOWEVER NO FURTHER SPECIFIC INFORMATION HAS BEEN RECEIVED.

    Description of Event or Problem · 1

    IT WAS ALLEGED THAT A PATIENT WAS SENT TO AN ORAL SURGEON TO REMOVE DISTAL END THAT DID NOT HOLD AND LODGED INTO PATIENTS CHEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    813821 ETM FLUSH CUT DISTAL-END CUTTER WITH SAFETY HOLD ETM DISTAL CUTTER EKD ORMCO CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other