BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    J-VAC RESERVOIRS

    MDR report key: 4093394 · Received September 16, 2014

    Report

    Report Number
    2210968-2014-12904
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 25, 2014
    Report Date
    August 27, 2014
    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: TO DATE, THE DEVICE HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED FOR EVALUATION, ANY FURTHER INFO DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

    Additional Manufacturer Narrative · 1

    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 SURGICAL PROCEDURE AND A RESERVOIR WAS CONNECTED TO A DRAIN. PRIOR TO USE OF THE RESERVOIR, THE PATIENT HAD DEVELOPED A HEMATOMA DURING USE OF OTHER COMPANY'S RESERVOIR. THE RESERVOIR WAS UNABLE TO SUCTION AND THE PATIENT DEVELOPED A HEMATOMA. THE RESERVOIR WAS REPLACED WITH ANOTHER LIKE DEVICE AND IT WORKED PROPERLY. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION REQUIRED FOR THE HEMATOMA. THE CURRENT CONDITION OF THE PATIENT WAS REPORTED AS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571445 J-VAC RESERVOIRS WOUND DRAINAGE SYSTEM KOG ETHICON INC. UNK JT7895

    Patients

    Seq Age Sex Outcome Treatment
    1