BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE GENERAL SURGERY TRAY (KIT)

    MDR report key: 6289258 · Received January 31, 2017

    Report

    Report Number
    6289258
    Event Type
    Malfunction
    Date Received
    January 31, 2017
    Date of Event
    December 22, 2016
    Report Date
    January 18, 2017
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    LRO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    NOTED BY SCRUB TECH WHEN SETTING UP FOR CASE THE TIP OF THE NUMBER 10 KNIFE BLADE (MFG BARD PARKER, LOT#0103547) HAD A SCORE IN IT. THE BLADE WAS INCLUDED IN THE MEDLINE GENERAL PACK ((B)(4), LOT #16JB3994. BLADE REMOVED FROM THE FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72003 MEDLINE GENERAL SURGERY TRAY (KIT) BLADE, SCALPEL LRO MEDLINE INDUSTRIES, INC. 103547

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR