BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    J-VAC RESERVOIR

    MDR report key: 2052248 · Received April 12, 2011

    Report

    Report Number
    2210968-2011-00416
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Report Date
    March 15, 2011
    Manufacturer
    DEGANIA SILICON LTD.
    Product Code
    KOG
    PMA / PMN Number
    K953655
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 04/12/2011. (B)(4). RESULTS: DURING THE FUNCTIONAL TESTING, THE BULB WAS FUNCTIONING PROPERLY. THE VISUAL EXAMINATION FOUND THE " LIPS" OF THE ANTI-REFLUX VALVE ARE ALMOST FULLY STUCK ONE TO ANOTHER. CONCLUSION: THE DEVICE WAS RECEIVED IN A CONDITION WHICH DOES NOT MEET SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE ON A PATIENT, THE " TIP OF THE CONNECTOR" WAS NOTED TO BE DAMAGED AND WAS FLATTENED AT ONE END. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 J-VAC RESERVOIR WOUND DRAINAGE SYSTEM KOG DEGANIA SILICON LTD. NA J102981

    Patients

    Seq Age Sex Outcome Treatment
    1