BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 3203731 · Received May 31, 2013

    Report

    Report Number
    3008011779-2013-00001
    Event Type
    Injury
    Date Received
    May 31, 2013
    Date of Event
    April 30, 2013
    Report Date
    May 30, 2013
    Manufacturer
    EXACT MEDICAL MANUFACTURING INC.
    Product Code
    FYA
    PMA / PMN Number
    K120045
    Removal / Correction Number
    2013007
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    PR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    SUSPECTED FLUID STRIKE THROUGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242208 NA FYA EXACT MEDICAL MANUFACTURING INC. 1002493 1742APB5/1362APB2

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other