BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLAKE DRAIN

    MDR report key: 1892781 · Received November 3, 2010

    Report

    Report Number
    2210968-2010-01415
    Event Type
    Malfunction
    Date Received
    November 3, 2010
    Date of Event
    October 8, 2010
    Report Date
    October 8, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    KOG
    PMA / PMN Number
    K953655
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - POOR WOUND DRAINAGE. CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFO DERIVED FROM THE EVAL WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2010-01416. THE SAME PT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT A FACE LIFT (RHYTIDECTOMY) PROCEDURE ON (B)(6) 2010 AND A 10 FR DRAIN WAS PLACED. THE DRAIN WAS NOT DRAINING AND THE PT DEVELOPED AN ADVANCED HEMATOMA ON THE FACE. THE SURGEON OPINES THAT THE DRAIN IS TOO SOFT, THEREFORE, THE DRAIN GETS FLAT AND LOSES ITS FUNCTIONALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLAKE DRAIN WOUND DRAINAGE SYSTEM KOG ETHICON, INC. NA 50832ISP

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK