BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    J-VAC RESERVOIR

    MDR report key: 2042557 · Received April 6, 2011

    Report

    Report Number
    2210968-2011-00389
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 9, 2011
    Report Date
    March 11, 2011
    Manufacturer
    NI
    Product Code
    KOG
    PMA / PMN Number
    K953655
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS - THE ACTUAL DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION. FUNCTIONAL TEST WAS PERFORMED AND FUNCTIONAL FAILURE WAS OBSERVED AS THE BULB DID NOT INFLATE WHEN THE AIR WAS COMPRESSED OUT, THE ANTIREFLUX VALVE EDGES VISIBLY DETERIORATED AND STUCK TOGETHER. CONCLUSION: THE DEVICE WAS RECEIVED IN A CONDITION WHICH DOES NOT MEET SPECIFICATION.

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 04/06/2011. (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 LEFT PAROTID GLAND TUMOR RESECTION PROCEDURE ON (B)(6) 2011. THE DRAIN WAS PLACED AT THE NECK AND CONNECTED TO THE RESERVOIR. THE RESERVOIR COULD NOT INFLATE AND SUCTION WHEN IT WAS ACTIVATED. 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 NI NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention