BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEDSTROEM FILE

    MDR report key: 2080113 · Received April 6, 2011

    Report

    Report Number
    9611053-2011-00001
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Report Date
    March 7, 2011
    Manufacturer
    DENTSPLY TULSA DENTAL SPECIALTIES
    Product Code
    EKS
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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 MULTIPLE HEDSTROEM FILES SEPARATED; THE SEPARATED PIECES WERE RETRIEVED WITHOUT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEDSTROEM FILE EKS DENTSPLY TULSA DENTAL SPECIALTIES 7862820

    Patients

    Seq Age Sex Outcome Treatment
    1