BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLAKE DRAIN

    MDR report key: 1842852 · Received September 17, 2010

    Report

    Report Number
    2210968-2010-01142
    Event Type
    Injury
    Date Received
    September 17, 2010
    Date of Event
    August 16, 2010
    Report Date
    August 17, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    KOG
    PMA / PMN Number
    K953655
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED, IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE INTERNATIONAL AFFILIATE REPORTS THE FOLLOWING POSSIBLE BATCH NUMBERS: BATCH 50348ISP, MFG DATE: 11/06/2009, EXP DATE: 11/30/2014. BATCH 50458ISP, MFG DATE: 11/20/2009, EXP DATE: 08/31/2014. BATCH 50522ISP, MFG DATE: UNK, EXP DATE: UNK. THIS IS ONE OF FOUR MEDWATCHES BEING SUBMITTED AS FOUR DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2010-01143, 2210968-2010-01144, AND 2210968-2010-01145. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A VALVE REPLACEMENT PROCEDURE ON (B)(6) 2010, AND A DRAIN WAS PLACED IN THE PERICARDIUM AND A RESERVOIR WAS CONNECTED. AFTER CLOSING THE SURGICAL WOUND SITE, THE WOUND WAS NOT DRAINING. THE SURGEON DISCONNECTED THE RESERVOIR TO CHECK THE DRAIN. THE DRAIN FUNCTIONED WITH AN ASPIRATION TUBE, SO THE SURGEON FOUND THAT THE DRAIN WORKED NORMALLY. THE SURGEON CUT OPEN A PART OF THE SUTURED FASCIA (DID NOT OPEN THE STERNUM BONE) TO EXCHANGE THE DRAIN. A NEW DRAIN WAS PLACED IN THE MEDIASTINAL SPACE AND THE FASCIA WAS SUTURED WITH A FEW STITCHES. THE NEW DRAIN ALSO WORKED NORMALLY. THE SURGEON CONFIRMED THAT THE DRAIN HAD NO FAILURE, HOWEVER, IT WAS REPLACED JUST TO BE SAFE. THE PATIENT IS HOSPITALIZED AND RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLAKE DRAIN WOUND DRAINAGE SYSTEM KOG ETHICON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention