BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    J-VAC RESERVOIR

    MDR report key: 2051905 · Received March 14, 2011

    Report

    Report Number
    2210968-2011-00267
    Event Type
    Malfunction
    Date Received
    March 14, 2011
    Date of Event
    February 3, 2011
    Report Date
    February 9, 2011
    Manufacturer
    ETHICON, INC.
    Product Code
    KOG
    PMA / PMN Number
    K953655
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADD'L INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA. THIS IS ONE OF FIVE MEDWATCHES BEING SUBMITTED AS FIVE DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2011-00263, 2210968-2011-00264, 22100968-2011-00265 AND 22100968-2011-00267. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2011 AND A DRAIN AND RESERVOIR WERE USED ON THE SIDE OF THE FACE. PRIOR TO USE ON THE PATIENT, WHEN THE BULB WAS SQUEEZED AND THE STOPPER CAP WAS REPLACED, THE BULB WOULD NOT RE-INFLATE. THERE WAS NO ADVERSE PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 J-VAC RESERVOIR WOUND DRAINAGE SYSTEM KOG ETHICON, INC. NA J101077

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK