BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESOURCE CRANIOTOMY PACK

    MDR report key: 2101364 · Received May 19, 2011

    Report

    Report Number
    2101364
    Event Type
    Malfunction
    Date Received
    May 19, 2011
    Date of Event
    May 11, 2011
    Report Date
    May 19, 2011
    Manufacturer
    CARDINAL
    Product Code
    LRP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    HAIR FOUND ON SPONGES INSIDE STERILE CUSTOM PACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESOURCE CRANIOTOMY PACK TRAY, SURGICAL LRP CARDINAL SNEW1CRHFA CS 214-FR

    Patients

    Seq Age Sex Outcome Treatment
    1