BEUDAMED
    FDA Adverse Event Other Summary report: N

    MICROTARGETING PLATFORM

    MDR report key: 2969661 · Received February 13, 2013

    Report

    Report Number
    3005677147-2013-00001
    Event Type
    Other
    Date Received
    February 13, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 17, 2013
    Manufacturer
    FHC, INC.
    Product Code
    HAW
    PMA / PMN Number
    K092192
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE 4 LEGGED UNILATERAL PLATFORM IS A PART OF A PROJECT (PJ348) WHICH HAS NOT BEEN DESIGN TRANSFERRED. THE 4 LEGGED UNILATERAL PLATFORM HOWEVER IS COMPLETE AND READY TO BE DESIGN TRANSFERRED ONCE PROJECT REVIEW IS COMPLETE. IMPROVEMENTS FOR CLARITY HAVE BEEN MADE TO THE PROCESS DOCUMENTATION TO ENHANCE THE UNDERSTANDING OF THE PRODUCT DEVELOPMENT CYCLE AND DESIGN CONTROL PROCESS TO AVOID THIS TYPE OF AN ISSUE MOVING FORWARD.

    Description of Event or Problem · 1

    DURING IN-HOUSE DOCUMENTATION REVIEW OF THE PLATFORM INSPECTION PAPERWORK, PROCESSING AND SHIPPING 4-LEGGED PLATFORMS WITH IMPROPER LABELLING AND AUTHORIZATION TO PROCEED WAS IDENTIFIED. AFTER REVIEW IT WAS FOUND THAT A TOTAL OF EIGHT (8) 4 LEGGED UNILATERAL PLATFORMS WERE SENT OUT TO CUSTOMERS. DOCUMENTED MFG AND INSPECTION PROCEDURES WERE FOLLOWED FOR ALL THE PLATFORMS SHIPPED. ALL THE SURGERIES USING THE 4 LEGGED UNILATERAL PLATFORMS WERE PERFORMED AND COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63844 MICROTARGETING PLATFORM PLATFORM HAW FHC, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK