BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HU-FRIEDY METZENBAUM PERMASHARP SCISSORS

    MDR report key: 6734390 · Received July 21, 2017

    Report

    Report Number
    1416605-2017-00004
    Event Type
    Injury
    Date Received
    July 21, 2017
    Date of Event
    June 15, 2017
    Report Date
    July 21, 2017
    Manufacturer
    HU-FRIEDY MFG. CO., LLC
    Product Code
    EGN
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO RELEVANT HISTORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO HU-FRIEDY MFG. (B)(6) THAT DURING AN ORAL SURGERY PROCEDURE, THE INSTRUMENT BROKE IN THE PATIENT'S MOUTH. THE BROKEN TIP WAS SWALLOWED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514585 HU-FRIEDY METZENBAUM PERMASHARP SCISSORS SCISSORS, SURGICAL TISSUE, DENTAL EGN HU-FRIEDY MFG. CO., LLC S5069 0415

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Other