BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLAKE DRAIN

    MDR report key: 1861283 · Received October 1, 2010

    Report

    Report Number
    2210968-2010-01246
    Event Type
    Malfunction
    Date Received
    October 1, 2010
    Date of Event
    September 2, 2010
    Report Date
    September 2, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    KOG
    PMA / PMN Number
    P953655
    Removal / Correction Number
    NA
    Product Problem
    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 INFO DERIVED FROM THE EVAL WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. THIS IS ONE OF TWO MEDWATCHES BEEN SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2010-01245. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2010 AND A DRAIN AND RESERVOIR WERE PLACED AT THE LACTEAL GLAND AND FUNCTIONED AS INTENDED. ON (B)(6) 2010, IT WAS FOUND THAT THE RESERVOIR DID NOT SUCTION, SO THE DRAIN AND RESERVOIR WERE REMOVED FROM THE PATIENT'S BODY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

    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 UNK