BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SD/PD SERIES LONG STRAIGHT ATTACHMENT

    MDR report key: 8784630 · Received July 12, 2019

    Report

    Report Number
    0001811755-2019-02255
    Event Type
    Malfunction
    Date Received
    July 12, 2019
    Date of Event
    June 17, 2019
    Report Date
    July 12, 2019
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    ERL
    UDI-DI
    04546540369963
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE OVERHEATED DURING A PROCEDURE AT THE USER FACILITY. THE USER FACILITY REPORTED THERE WERE NO MEDICAL INTERVENTIONS, SURGICAL DELAY, OR ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577296 SD/PD SERIES LONG STRAIGHT ATTACHMENT DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL STRYKER INSTRUMENTS-KALAMAZOO 04546540369963

    Patients

    Seq Age Sex Outcome Treatment
    1