BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SD/PD SERIES XL ANGLED ATTACHMENT

    MDR report key: 8784635 · Received July 12, 2019

    Report

    Report Number
    0001811755-2019-02261
    Event Type
    Malfunction
    Date Received
    July 12, 2019
    Date of Event
    June 22, 2019
    Report Date
    July 12, 2019
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    ERL
    UDI-DI
    04546540369994
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE HAD HEAT DURING TESTING CONDUCTED BY A MANUFACTURER FIELD SERVICE TECHNICIAN AT THE USER FACILITY. NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577294 SD/PD SERIES XL ANGLED ATTACHMENT DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL STRYKER INSTRUMENTS-KALAMAZOO 04546540369994

    Patients

    Seq Age Sex Outcome Treatment
    1