BEUDAMED
    FDA Adverse Event Injury Summary report: N

    J-VAC RESERVOIR

    MDR report key: 1883818 · Received October 22, 2010

    Report

    Report Number
    2210968-2010-01354
    Event Type
    Injury
    Date Received
    October 22, 2010
    Date of Event
    September 15, 2010
    Report Date
    September 21, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    KOG
    PMA / PMN Number
    K953655
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION CODE: 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 PT UNDERWENT A ABDOMINOPERINEAL RESECTION OF THE RECTUM ON (B)(6) 2010 AND A RESERVOIR WAS PLACED. THERE WAS NO FLUID COLLECTED IN THE RESERVOIR FOR THREE DAYS. ON (B)(6) 2010, THE SURGEON DISCONNECTED THE DRAIN FROM THE RESERVOIR TO EXCHANGE THE RESERVOIR, THEN FLUID CAME OUT OF THE DRAIN. THE SURGEON EXCHANGED THE RESERVOIR FOR NEW ONE WHICH WORKED NORMALLY. AFTER THE SURGERY, THE PT EXPERIENCED FEVER AND A SURGICAL SITE INFECTION AT THE SURFACE LAYER. THE SURGEON PRESCRIBED ANTIBIOTICS FOR FIVE DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 J-VAC RESERVOIR WOUND DRAINAGE SYSTEM KOG ETHICON, INC. NA JT7461

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention