BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    J-VAC RESERVOIR

    MDR report key: 1823359 · Received August 30, 2010

    Report

    Report Number
    2210968-2010-00992
    Event Type
    Malfunction
    Date Received
    August 30, 2010
    Date of Event
    July 22, 2010
    Report Date
    July 29, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    GCY
    PMA / PMN Number
    K953655
    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 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 STOMACH SURGERY PROCEDURE ON (B)(6) 2010. A DRAIN WAS PLACED AND A RESERVOIR WAS CONNECTED. THEY FUNCTIONED PROPERLY UPON FIRST ACTIVATION. ON (B)(6) 2010, THERE WAS INADEQUATE SUCTION IN THE RESERVOIR. THE NURSE SAID SHE DID NOT MILK THE DRAIN OFTEN. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 J-VAC RESERVOIR WOUND DRAINAGE SYSTEM GCY ETHICON, INC. NA JT7356

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK