BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    J-VAC RESERVOIR

    MDR report key: 2070854 · Received April 27, 2011

    Report

    Report Number
    2210968-2011-00524
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Report Date
    April 8, 2011
    Manufacturer
    ETHICON
    Product Code
    KOG
    PMA / PMN Number
    K953655
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE EVENT WAS DISCOVERED UPON REMOVAL OF THE DRAIN FROM THE PATIENT SO NO OTHER PRODUCT WAS USED. ALSO THERE WAS NO ADVERSE PATIENT CONSEQUENCES AND CURRENTLY THE PATIENT IS FINE.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SURGICAL PROCEDURE ON AN UNKNOWN DATE AND A RESERVOIR WAS USED. PART OF THE RESERVOIR WAS FOUND FLOATING IN THE RESERVOIR. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 J-VAC RESERVOIR WOUND DRAINAGE SYSTEM KOG ETHICON NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1