BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    J-VAC RESERVOIR

    MDR report key: 1034050 · Received April 24, 2008

    Report

    Report Number
    2210968-2008-00282
    Event Type
    Malfunction
    Date Received
    April 24, 2008
    Date of Event
    March 25, 2008
    Report Date
    March 25, 2008
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFO DERIVED FROM THE EVAL WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. A REVIEW OF THE BATCH MGF RECORDS WAS CONDUCTED. THIS REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    INTL CUSTOMER REPORTED THAT THE DEVICE FAILED TO DRAIN AFTER THE ATTACHED DRAIN WAS MILKED. THE RESERVOIR WAS REMOVED FROM SVC AND EXCHANGED. NO ADVERSE PT 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 JT7087

    Patients

    Seq Age Sex Outcome Treatment
    1 DRAIN - SURGICAL - NOT SPECIFIED