BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEDSTROEM FILE

    MDR report key: 2082140 · Received April 27, 2011

    Report

    Report Number
    8031010-2011-00048
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 28, 2011
    Manufacturer
    DENTSPLY MAILLEFER
    Product Code
    EKS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE NO SERIOUS INJURY OCCURRED, THERE HAS BEEN A REPORT RECEIVED IN THE PAST TWO YEARS INVOLVING A MALFUNCTION OF THIS DEVICE THAT CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THEREFORE, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803.

    Description of Event or Problem · 1

    IN THIS EVENT, IT WAS REPORTED THAT THE HANDLE OF A HEDSTROEM FILE SEPARATED DURING USE; THE SEPARATED PIECE WAS RETRIEVED WITHOUT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEDSTROEM FILE EKS DENTSPLY MAILLEFER

    Patients

    Seq Age Sex Outcome Treatment
    1