BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

    MDR report key: 7563994 · Received June 2, 2018

    Report

    Report Number
    1020279-2018-01029
    Event Type
    Injury
    Date Received
    June 2, 2018
    Date of Event
    May 28, 2018
    Report Date
    August 8, 2018
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    MDM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ASSOCIATED COMPLAINT DEVICES WERE NOT RETURNED. A CLINICAL EVALUATION WAS CONDUCTED AND NO ADDITIONAL CLINICAL INFORMATION HAS BEEN PROVIDED FOR INCLUSION IN THIS INVESTIGATION. HOWEVER, IT WAS REPORTED THERE WAS 30 MINUTES TO 1 HOUR DELAY IN THE PROCEDURE THAT DID NOT CAUSE HARM TO THE PATIENT. NO FURTHER CLINICAL/MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME. WITHOUT THE ACTUAL PRODUCT INVOLVED AND/OR DEVICE INFORMATION, OUR INVESTIGATION CANNOT PROCEED. IF THE DEVICE OR NEW INFORMATION IS RECEIVED IN THE FUTURE, THIS COMPLAINT CAN BE RE-OPENED. NO FURTHER ACTIONS ARE BEING TAKEN AT THIS TIME. WE CONSIDER THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED A DELAY OF MORE THAN 30 MINUTES DUE TO DAMAGED GUIDE WIRE GUN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406182 INSTRUMENT, MANUAL, SURGICAL, GENERAL USE MDM SMITH & NEPHEW, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention