BEUDAMED
    FDA Adverse Event Other Summary report: N

    DEROYAL

    MDR report key: 3011162 · Received March 15, 2013

    Report

    Report Number
    3006851902-2013-00002
    Event Type
    Other
    Date Received
    March 15, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 5, 2013
    Manufacturer
    DEROYAL INTERCONTINENTAL, S.R.L.
    Product Code
    IPY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEROYAL: RETURN OF THE SAMPLE HAS BEEN REQUESTED. THE INVESTIGATION INTO THE ROOT CAUSE OF THIS REPORT HAS NOT BEEN COMPLETED AT THIS TIME.

    Description of Event or Problem · 1

    THE MEDICAL FACILITY REPORTED THAT ONE OF CABLE HAS FRAYED CAUSING THE END USER TO STAB OR POKE HER FINGERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110506 DEROYAL IPY - ORTHOSIS, LUMBO-SACRAL IPY DEROYAL INTERCONTINENTAL, S.R.L.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other