BEUDAMED
    FDA Adverse Event Death Summary report: N

    BLAKE DRAIN

    MDR report key: 2119051 · Received June 9, 2011

    Report

    Report Number
    2210968-2011-00753
    Event Type
    Death
    Date Received
    June 9, 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
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 FOUR MEDWATCHES BEING SUBMITTED AS FOUR DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCHES 2210968-2011-00752, 2210968-2011-00754, AND 2210968-2011-00755. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    (B)(4). NARRATIVE - IT WAS REPORTED THAT THE PATIENT DIED ON (B)(6) 2011 WITH THE FOLLOWING: DEEP MEDIASTINAL INFECTION ASSOCIATED WITH ENDOCARDITIS. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: (B)(4) 2011. ADDITIONAL INFORMATION: - NARRATIVE - IT WAS REPORTED THAT THE PATIENT EXPIRED ON AN UNKNOWN DATE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. (B)(4). IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN AORTIC VALVULOPLASTY AND MITRALIC VALVULOPLASTY ON (B)(6) 2011. ON (B)(6) 2011, THE PATIENT UNDERWENT AN URGENT ROBICSEK STERNAL CLOSURE PROCEDURE AND A DRAIN WAS PLACED. THE PATIENT DEVELOPED AN INFECTION AND UNDERWENT AN ADDITIONAL UNKNOWN SURGICAL PROCEDURE ON (B)(6) 2011 BECAUSE OF THE PRESENCE OF THIS INFECTION. THIS WAS THE ONLY INFORMATION AVAILABLE AND 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 J103148

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death| R