BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLAKE DRAIN

    MDR report key: 2141798 · Received June 27, 2011

    Report

    Report Number
    2210968-2011-00834
    Event Type
    Injury
    Date Received
    June 27, 2011
    Report Date
    June 1, 2011
    Manufacturer
    ETHICON, INC
    Product Code
    KOG
    PMA / PMN Number
    K953655
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LYMPHOMA REMOVAL PROCEDURE FROM THE UPPER THIGH AND A DRAIN WAS PLACED. THE DRAIN WAS REMOVED FOUR DAYS POSTOPERATIVELY. THE PATIENT EXPERIENCED PAIN, SWELLING AND REDNESS IN THE UPPER THIGH AND DIFFICULTY WALKING. THE PATIENT WAS GIVEN ANTIBIOICS FOR A POSSIBLE INFECTION. CURRENTLY, THE PATIENT STILL HAS PAIN.

    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