BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLAKE DRAIN

    MDR report key: 2032049 · Received March 28, 2011

    Report

    Report Number
    2210968-2011-00356
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    February 24, 2011
    Report Date
    February 28, 2011
    Manufacturer
    NI
    Product Code
    KOG
    PMA / PMN Number
    K953655
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. A FUNCTIONAL TEST WAS PERFORMED. THE DISTAL END OF THE DRAIN WAS PUT INTO A RESERVOIR WITH WATER AND THE BULB WAS SQUEEZED. THE SYSTEM WAS FUNCTIONING PROPERLY. THE BULB WAS FILLING IN WITH THE WATER.

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 03/28/2011. (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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY PROCEDURE ON (B)(6) 2011 AND A DRAIN WAS PLACED. AFTER THE PATIENT WAS MOVED TO THE WARD, THERE WAS NO DRAIN SUCTION. THE DRAIN SIDE OF THE ADAPTOR WAS FOUND TO BE CLOGGED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLAKE DRAIN WOUND DRAINAGE SYSTEM KOG NI NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1