BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    J-VAC RESERVOIR

    MDR report key: 1982176 · Received January 18, 2011

    Report

    Report Number
    2210968-2011-00041
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Date of Event
    December 16, 2010
    Report Date
    December 17, 2010
    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

    (B)(4). CONCLUSION: 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A POSTERIOR SPINAL FUSION PROCEDURE ON (B)(6)2010 AND A RESERVOIR WAS USED. UPON FIRST ACTIVATION, THE RESERVOIR DID NOT INFLATE. THE SURGEON EXCHANGED THE RESERVOIR FOR ANOTHER PRODUCT WHICH WORKED NORMALLY. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 J-VAC RESERVOIR WOULD DRAINAGE SYSTEM KOG ETHICON, INC. NA JT7462

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK