BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLAKE DRAIN

    MDR report key: 2083590 · Received May 10, 2011

    Report

    Report Number
    2210968-2011-00598
    Event Type
    Injury
    Date Received
    May 10, 2011
    Date of Event
    April 14, 2011
    Report Date
    April 15, 2011
    Manufacturer
    ETHICON, INC
    Product Code
    KOG
    PMA / PMN Number
    K953655
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFECTION. CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2011-00599. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A BILATERAL MASTECTOMY AND DOUBLE BREAST IMPLANT PROCEDURE ON (B)(6) 2011 AND A DRAIN WAS INSERTED. THE PATIENT PRESENTED TO SUNSHINE HOSPITAL ON (B)(6) 2011 THEN TRANSFERRED TO PETER MACCALLUM ON (B)(6) 2011. THE PATIENT WAS UNDERGOING EMERGENCY SURGERY FOR WASHOUT AND DRAINAGE AND MAY NEED THE IMPLANTS REMOVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention