BEUDAMED
    FDA Adverse Event Injury Summary report: N

    50-12546 NEURO TRAY

    MDR report key: 324935 · Received April 5, 2001

    Report

    Report Number
    1060680-2001-00001
    Event Type
    Injury
    Date Received
    April 5, 2001
    Date of Event
    February 19, 2001
    Report Date
    March 23, 2001
    Manufacturer
    DEROYAL INDUSTRIES, INC
    Product Code
    LRO
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER CLAIMS THAT A PT RECEIVED A BURN FROM THE GROUNDING PAD THAT IS PACKAGED WITHIN THE CONVENIENCE KIT. THE BURN OCCURRED ON THE RIGHT THIGH AT THE SITE WHERE A SKIN GRAFT WAS BEING TAKEN DURING A CERVICAL FUSION OF THE NECK. HOSP REFUSED TO RETURN DEVICE. HOSP DID NOT RELEASE COMPLETE DETAILS ABOUT PT OR INJURY DUE TO THE COVENANT OF CONFIDENTIALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14970 50-12546 NEURO TRAY CTN CUST PROCEDURAL TRAY NEURO LRO DEROYAL INDUSTRIES, INC 1 548372

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention