BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLAKE DRAIN

    MDR report key: 1942420 · Received December 17, 2010

    Report

    Report Number
    2210968-2010-01707
    Event Type
    Injury
    Date Received
    December 17, 2010
    Report Date
    November 22, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    KOG
    PMA / PMN Number
    K953655
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - INFECTION OCCURRED. CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2010-01708. THE SAME PT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT AN UNK PROCEDURE ON (B)(6) 2010 AND A DRAIN WAS USED. ON THE PT'S RIGHT SIDE UNDERNEATH THE ARM WHERE THE DRAINS TOUCHED HER SKIN, A BLISTER OCCURRED. THE BLISTER MEASURED APPROX 1/2 INCH WIDE AND 1 AND 1/2 INCHES LONG. THE DRAIN REMAINED IN PLACE FOR 2 AND 1/2 WEEKS. THE DRAIN WAS REMOVED AND WITHIN LESS THAN 12 HOURS, THE PT HAD A TEMPERATURE AND CHILLS. THE PT FOLLOWED UP WITH THE SURGEON THE NEXT DAY AND WAS STARTED ON ANTIBIOTIC THERAPY ON A FRIDAY. THE FOLLOWING TUESDAY, THE PT WAS ADMITTED TO THE HOSPITAL AND WAS STARTED ON IV ANTIBIOTICS. ON WEDNESDAY, THE PT WAS NOT IMPROVING AND WAS TAKEN TO SURGERY TO HAVE EXPANDERS REMOVED. CULTURES WERE TAKEN WHICH REVEALED A (B)(6) INFECTION. THE PT HAS SEEN AN ALLERGIST DUE TO THE REACTION.

    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 Required Intervention