BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNK

    MDR report key: 673962 · Received February 10, 2006

    Report

    Report Number
    9615741-2006-00002
    Event Type
    Other
    Date Received
    February 10, 2006
    Report Date
    February 9, 2006
    Manufacturer
    NEWDEAL S.A.
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE REPORTER REPORTED TO NEWDEAL THAT THE PATIENT INCURRED A FUNGAL INFECTION (SITE UNSPECIFIED). PER REPORTER THE FUNGAL INFECTION WAS NOT DUE TO THE DEVICE. THE PRODUCT ID WAS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK ICOS SCREW HWC NEWDEAL S.A. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN