BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN INTACT CONSOLE

    MDR report key: 6993514 · Received November 1, 2017

    Report

    Report Number
    1226420-2017-00265
    Event Type
    Injury
    Date Received
    November 1, 2017
    Date of Event
    October 14, 2016
    Report Date
    November 1, 2017
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    KNW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT: (B)(4). PATIENT INFORMATION INCOMPLETE, MISSING PATIENT INFORMATION AND UNABLE TO BE OBTAINED FROM THE CUSTOMER. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED 5 OUT OF 47 PATIENTS DEVELOPED AN INFECTION. THE PATIENTS WERE TREATED PER HOSPITAL¿S MASTITIS PROTOCOL. THIS RECORD REPRESENTS PATIENT 3 OF 5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773041 UNKNOWN INTACT CONSOLE INSTRUMENT, BIOPSY KNW MEDTRONIC ADVANCED ENERGY, LLC MAE UNK INTACT GEN

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention