BEUDAMED
    FDA Adverse Event Death Summary report: N

    BLAKE DRAIN

    MDR report key: 2063282 · Received April 19, 2011

    Report

    Report Number
    2210968-2011-00467
    Event Type
    Death
    Date Received
    April 19, 2011
    Report Date
    March 25, 2011
    Manufacturer
    ETHICON INC
    Product Code
    KOG
    PMA / PMN Number
    K953655
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: (B)(4) 2011.THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE FOLLOWING IS A POSSIBLE BATCH NUMBER: BATCH J107711, MFG DATE: 07/01/2009, EXP DATE: 07/31/2015.IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS FOR THE POSSIBLE BATCH NUMBER WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    (B)(4). INFECTION OCCURRED. CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE FOLLOWING IS A POSSIBLE BATCH NUMBER: BATCH J107711.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPEN HEART SURGICAL PROCEDURE ON (B)(6) 2011 AND A DRAIN WAS PLACED. THE PATIENT EXPERIENCED ONSET OF INFECTION TEN TO ELEVEN DAYS AFTER THE PROCEDURE. THE PATIENT EXPIRED ON AN UNKNOWN DATE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    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 Death| L| R