BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLAKE DRAIN

    MDR report key: 2063495 · Received April 19, 2011

    Report

    Report Number
    2210968-2011-00458
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Report Date
    March 23, 2011
    Manufacturer
    ETHICON, INC
    Product Code
    KOG
    PMA / PMN Number
    K953655
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    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. THIS IS ONE OF FOUR MEDWATCHES BEING SUBMITTED AS FOUR DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2011-00455, MEDWATCH 2210968-2011-00456, AND MEDWATCH 2210968-2011-00457. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DRAIN WAS USED ON AN UNKNOWN DATE AND WHEN IT WAS CONNECTED IT WOULD NOT CREATE A VACCUM AND DRAIN INTO THE BULB RESERVOIR. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. 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