BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNX CADENCE VASCULAR CLOSURE DEVICE 6/7F

    MDR report key: 2853102 · Received July 2, 2012

    Report

    Report Number
    3004939290-2012-00213
    Event Type
    Injury
    Date Received
    July 2, 2012
    Date of Event
    April 6, 2012
    Report Date
    June 8, 2012
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED; THEREFORE, A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED. BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. A REVIEW OF THE LHR WAS NOT POSSIBLE AS THE LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    THE (B)(4) DISTRIBUTOR REPORTED THAT A PATIENT UNDERWENT A CATHETERIZATION PROCEDURE IN (B)(6) 2012. NO COMPLICATIONS WERE REPORTED DURING THE DEVICE DEPLOYMENT AND CLOSURE. A FEW DAYS AFTER THE CATHETERIZATION PROCEDURE, IT WAS ALLEGED THAT THE PATIENT GOT A BODY REACTION FROM THE DEVICE PEG. THE MATERIAL WAS SURGICALLY REMOVED FROM THE PATIENT ON (B)(6) 2012. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNX CADENCE VASCULAR CLOSURE DEVICE 6/7F MGB ACCESSCLOSURE, INC. MX6701 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention