BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEMIS 3000CC HIFLOW CANISTER

    MDR report key: 3647838 · Received January 13, 2014

    Report

    Report Number
    2133713-2014-00002
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    January 9, 2014
    Report Date
    January 13, 2014
    Manufacturer
    BEMIS MFG. CO.
    Product Code
    GCX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    USE OF THIS PRODUCT IN LIPOSUCTION IS CONTRAINDICATED IN THE INSTRUCTIONS FOR USE PROVIDED WITH THE PRODUCT. I FORWARDED A PDF COPY OF THE IFU TO COMPLAINANT, ALONG WITH INFO FOR OUR QUICK FIT LINER SYSTEM THAT IS RECOMMENDED FOR LIPOSUCTION.

    Description of Event or Problem · 1

    COMPLAINANT STATES THAT SUCTION CANISTER CRACKS IN THE BOTTOM DURING LIPOSUCTION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26391 BEMIS 3000CC HIFLOW CANISTER APPARATUS, SUCTION, VACUUM POWERED GCX BEMIS MFG. CO. 3002 055 20130926

    Patients

    Seq Age Sex Outcome Treatment
    1