BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    J-VAC RESERVOIR

    MDR report key: 821085 · Received January 19, 2007

    Report

    Report Number
    2210968-2007-00052
    Event Type
    Malfunction
    Date Received
    January 19, 2007
    Date of Event
    December 12, 2006
    Report Date
    December 20, 2006
    Manufacturer
    ETHICON, INC.
    Product Code
    GCY
    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

    CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED HAS BEEN REC'D, HOWEVER, THE PRODUCT EVAL IS NOT YET COMPLETE. ANY FURTHER INFO DERIVED FROM THE EVAL WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. THIS IS ONE OF FOUR MEDWATCH REPORTS BEING SUBMITTED AS FOUR SEPARATE DEVICES WERE USED. SEE 2210968-2007-00051, 2210968-2007-00052, 2210968-2007-00053 AND 210968-2007-00054 FOR ALL ASSOCIATED REPORTS. THE SAME PT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    INTERNATIONAL CUSTOMER REPORTED THAT THE DEVICE READILY INFLATED WITH AIR FROM A LEAK AT THE DEVICE CONNECTOR. NO ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 J-VAC RESERVOIR WOUND DRAINAGE SYSTEM GCY ETHICON, INC. NA 620530

    Patients

    Seq Age Sex Outcome Treatment
    1 YR DRAIN - BLAKE- CATALOG #2229