BEUDAMED
    FDA Adverse Event Death Summary report: N

    BLAKE DRAIN

    MDR report key: 2120593 · Received June 10, 2011

    Report

    Report Number
    2210968-2011-00741
    Event Type
    Death
    Date Received
    June 10, 2011
    Report Date
    May 19, 2011
    Manufacturer
    ETHICON
    Product Code
    KOG
    PMA / PMN Number
    K953655
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: (B)(4) 2011. (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT THORACIC SURGERY ON (B)(6) 2011 AND A DRAIN WAS PLACED. THE PATIENT DEVELOPED MEDIASTINITIS AND THE PATIENT DIED ON (B)(6) 2011. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLAKE DRAIN WOUND DRAINAGE SYSTEM KOG ETHICON NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| L| R