BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    J-VAC RESERVOIR

    MDR report key: 1063529 · Received June 18, 2008

    Report

    Report Number
    2210968-2008-00461
    Event Type
    Malfunction
    Date Received
    June 18, 2008
    Report Date
    May 23, 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

    DATE SENT TO THE FDA: 06/18/2008. 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. A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED. THIS REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA. THIS IS ONE OF TWO MEDWATCH REPORTS BEING SUBMITTED AS TWO SEPARATE DEVICES WERE USED. SEE 2210968-2008-00000 FOR THE OTHER MEDWATCH. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    INTERNATIONAL CUSTOMER REPORTED THAT THE DEVICE CAME INTO CONTACT WITH THE PATIENTS' BEDFRAME AND SUBSEQUENTLY DEVELOPED A PINHOLE LEAK SIX DAYS FOLLOWING INITIAL ACTIVATION OF THE DEVICE. THE DEVICE WAS REMOVED FROM SERVICE AND EXCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 J-VAC RESERVOIR WOUND DRAINAGE SYSTEM GCY ETHICON, INC. NA JT7129

    Patients

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