BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSAJET EXACT ASSY, 45 DEGREE X 14MM

    MDR report key: 10514431 · Received September 10, 2020

    Report

    Report Number
    8043484-2020-02814
    Event Type
    Malfunction
    Date Received
    September 10, 2020
    Date of Event
    August 17, 2020
    Report Date
    September 15, 2020
    Manufacturer
    SMITH & NEPHEW MEDICAL LTD.
    Product Code
    FQH
    PMA / PMN Number
    K110958
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H11: IT WAS INFORMED THAT THIS COMPLAINT IS A DUPLICATE AND WAS SUBMITTED TO THE FDA WITH THE MDR: 8043484-2020-02822.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDPIECE DIDN¿T WANT TO PRIME AT ALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    978674 VERSAJET EXACT ASSY, 45 DEGREE X 14MM LAVAGE, JET FQH SMITH & NEPHEW MEDICAL LTD. 50760712

    Patients

    Seq Age Sex Outcome Treatment
    1