BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    J-VAC RESERVOIR

    MDR report key: 2072168 · Received April 28, 2011

    Report

    Report Number
    2210968-2011-00509
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    March 17, 2011
    Report Date
    March 30, 2011
    Manufacturer
    ETHICON
    Product Code
    KOG
    PMA / PMN Number
    K953655
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 04/28/2011. (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 EAR SURGERY ON (B)(6) 2011 AND A RESERVOIR WAS USED. THE RESERVOIR HAD INADEQUATE SUCTION. THE RESERVOIR WAS REPLACED WITH A NEW 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 J108398I

    Patients

    Seq Age Sex Outcome Treatment
    1