BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEMIS 2000CC HI-FLOW SUCTION CANISTER

    MDR report key: 3000108 · Received February 8, 2013

    Report

    Report Number
    2133713-2013-00001
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 8, 2013
    Manufacturer
    BEMIS MFG. CO.
    Product Code
    GCX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER IS USING PRODUCT FOR A PROCEDURE WHICH WE DO NOT RECOMMEND. INSTRUCTIONS FOR USE PROVIDED WITH THE PRODUCT WARN THAT PRODUCT IS NOT RECOMMENDED FOR LIPOSUCTION.

    Description of Event or Problem · 1

    SURGERY CENTER REPORTED THAT THEY EXPERIENCED A CANISTER BREAK DURING A LIPOSUCTION PROCEDURE. THERE WERE NO PT CONSEQUENCES, BUT THE FAILURE CAUSED A HALF HOUR DELAY WHILE STAFF CLEANED UP THE MESS. REPORTER STATED THEY HAD PREVIOUSLY EXPERIENCED CRACKED CANISTERS DURING LIPOSUCTION, BUT HAD NOT PREVIOUSLY REPORTED THEM TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54965 BEMIS 2000CC HI-FLOW SUCTION CANISTER APPARATUS, VACUUM, SUCTION POWERED GCX BEMIS MFG. CO. 494410 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1