BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    J-VAC RESERVOIRS

    MDR report key: 3190316 · Received June 26, 2013

    Report

    Report Number
    2210968-2013-11191
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    May 27, 2013
    Report Date
    June 11, 2013
    Manufacturer
    ETHICON INC.
    Product Code
    KOG
    PMA / PMN Number
    K953655
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 SPINAL CANAL STENOSIS PROCEDURE ON (B)(6) 2013 AND A RESERVOIR WAS CONNECTED TO A DRAIN. THE RESERVOIR FUNCTIONED PROPERLY UPON FIRST ACTIVATION. AFTER TWO OR THREE HOURS, IT WAS FOUND THAT THE RESERVOIR WAS NOT SUCTIONING PROPERLY AND THE PATIENT COMPLAINED OF PAIN. THE PAIN RESOLVED WITHOUT MEDICAL OR SURGICAL INTERVENTION WITHIN FIVE HOURS. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291118 J-VAC RESERVOIRS WOUND DRAINAGE SYSTEM KOG ETHICON INC. UNK JT7855

    Patients

    Seq Age Sex Outcome Treatment
    1