BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    J-VAC RESERVOIRS

    MDR report key: 3253965 · Received July 30, 2013

    Report

    Report Number
    2210968-2013-15040
    Event Type
    Malfunction
    Date Received
    July 30, 2013
    Date of Event
    June 25, 2013
    Report Date
    July 16, 2013
    Manufacturer
    ETHICON INC.
    Product Code
    KOG
    PMA / PMN Number
    K953655
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: 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) 2013 AND A RESERVOIR WAS USED. PRIOR TO USE ON THE PATIENT, IT WAS NOTED THAT THE PACKAGE WAS IN A SINGLE PACKAGING, NOT IN DOUBLE-BARRIER PACKAGING. THE PRODUCT WAS NOT USED ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355525 J-VAC RESERVOIRS WOUND DRAINAGE SYSTEM KOG ETHICON INC. UNK JT7860

    Patients

    Seq Age Sex Outcome Treatment
    1