BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN PRODUCT

    MDR report key: 2131263 · Received June 16, 2011

    Report

    Report Number
    2210968-2011-00798
    Event Type
    Death
    Date Received
    June 16, 2011
    Date of Event
    May 23, 2011
    Report Date
    May 24, 2011
    Manufacturer
    ETHICON, INC
    Product Code
    KOG
    PMA / PMN Number
    K953655
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE: INFECTION. CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. ADDITIONAL INFORMATION: THERE ARE EIGHT POSSIBLE DEVICES INVOLVED IN THE EVENT AS FOLLOWS: BLAKE DRAIN 19FR R/F, PRODUCT CODE (B)(4), BATCH J104898 - QUANTITY (5). J-VAC RESERVOIR, PRODUCT CODE (B)(4), BATCH J1021304 - QUANTITY (1). ONE PRONG POLYCARBONATE CONNECTOR FOR A19FR BLAKE HUBLESS DRAIN, PRODUCT CODE (B)(4), BATCH J100776- QUANTITY (2).

    Additional Manufacturer Narrative · 1

    (B)(4). THERE ARE EIGHT POSSIBLE DEVICES INVOLVED IN THE EVENT AS FOLLOWS: BLAKE DRAIN 19FR R/F, PRODUCT CODE 2232, (B)(4), MFG DATE: 06/01/2010. EXP. DATE: 06/30/2015 - QUANTITY (5). J-VAC RESERVOIR, PRODUCT CODE 2160, (B)(4), MFG DATE: 11/01/2010, EXP. DATE: 11/30/2015 - QUANTITY (1). ONE PRONG POLYCARBONATE CONNECTOR FOR (B)(4) BLAKE HUBLESS DRAIN, PRODUCT CODE BCC1, (B)(4), MFG DATE: 04/01/2010, EXP DATE: 04/30/2015- QUANTITY (2). IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS FOR THE POSSIBLE BATCH NUMBERS WAS CONDUCTED AND THE BATCHES MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A THORACIC SURGICAL PROCEDURE ON AN UNKNOWN DATE AND TWO DRAINS, TWO DRAIN CONNECTORS AND ONE RESERVOIR WERE USED ON THE PATIENT. THE PATIENT UNDERWENT AN UNKNOWN RE-OPERATION AND THE TWO DRAINS WERE REMOVED AND THREE DRAINS WERE NEWLY PLACED. THE PATIENT DEVELOPED MEDIASTINITIS ON AN UNKNOWN DATE AND THE PATIENT EXPIRED ON (B)(6) 2011. ADDITIONAL PATIENT, EVENT AND PRODUCT INFORMATION HAS BEEN REQUESTED. NO FURTHER INFORMATION WAS MADE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN PRODUCT UNKNOWN KOG ETHICON, INC NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| L| R