BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLAKE DRAIN

    MDR report key: 2072207 · Received April 28, 2011

    Report

    Report Number
    2210968-2011-00527
    Event Type
    Injury
    Date Received
    April 28, 2011
    Report Date
    April 6, 2011
    Manufacturer
    ETHICON
    Product Code
    KOG
    PMA / PMN Number
    K953655
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 04/28/2011. (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 A BILATERAL MASTECTOMY ON (B)(6) 2011 AND A DRAIN WAS PLACED. THE DRAIN WAS REMOVED ON (B)(6) 2011. THE PATIENT DEVELOPED AN INFECTION ON ONE SIDE OF HER CHEST WALL. THE CULTURES SHOWED STAPH AUREUS WHICH WAS SENSITIVE TO FLUCLOXACILLIN. THE PATIENT WAS MANAGED AS AN OUTPATIENT AND THEN AS AN INPATIENT. THE PATIENT WAS RECOVERING WELL.

    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 75 YR Hospitalization| R