BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    J-VAC BULB RESERVOIR

    MDR report key: 2964281 · Received February 15, 2013

    Report

    Report Number
    2210968-2013-01231
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Report Date
    January 21, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    KOG
    PMA / PMN Number
    K953655
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A SURGICAL PROCEDURE ON AN UNKNOWN DATE AND A RESERVOIR WAS CONNECTED TO A DRAIN. WHILE PRIMING THE BULB THE ANTI REFLUX VALVE DISLODGED. ANOTHER LIKE DEVICE WAS USED AND THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69337 J-VAC BULB RESERVOIR WOUND DRAINAGE SYSTEM KOG ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1