BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    J-VAC RESERVOIR

    MDR report key: 1812726 · Received August 13, 2010

    Report

    Report Number
    2210968-2010-00928
    Event Type
    Malfunction
    Date Received
    August 13, 2010
    Date of Event
    July 9, 2010
    Report Date
    July 14, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    KOG
    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. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2010 AND A RESERVOIR WAS CONNECTED TO A DRAIN. THE SURGEON FOUND THAT THE JUNCTION AREA OF THE BOTTOM OF THE LOCKING PLATE WAS BROKEN WHEN HE FOLDED IT, BUT IT WORKED PROPERLY EVEN THOUGH THE JUNCTION AREA WAS BROKEN. IT WAS NOT HARD OR TIGHT TO FOLD, SO THE PATIENT USED IT ANYWAY WITH NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 J-VAC RESERVOIR WOUND DRAINAGE SYSTEM KOG ETHICON, INC. NA JT7405

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK