BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    J-VAC RESERVOIRS

    MDR report key: 3894147 · Received June 25, 2014

    Report

    Report Number
    2210968-2014-08192
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 6, 2014
    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

    IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: TO DATE, THE DEVICE HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED FOR EVALUATION, ANY FURTHER INFO 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 SURGICAL PROCEDURE AND A RESERVOIR WAS ATTACHED TO A DRAIN. AFTER THE BLOOD INSIDE THE RESERVOIR WAS DISCARDED, IT WAS FOUND THAT THERE WAS NO NEGATIVE PRESSURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. THE CURRENT CONDITION OF THE PATIENT IS STABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371190 J-VAC RESERVOIRS WOUND DRAINAGE SYSTEM KOG ETHICON INC. UNK JT7977

    Patients

    Seq Age Sex Outcome Treatment
    1