BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEMIS QUICK-FIT 3000CC SUCTION LINER

    MDR report key: 1463773 · Received June 18, 2009

    Report

    Report Number
    2133713-2009-00004
    Event Type
    Malfunction
    Date Received
    June 18, 2009
    Date of Event
    May 27, 2009
    Report Date
    June 17, 2009
    Manufacturer
    BEMIS MFG. CO.
    Product Code
    KDQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS MADE IN DECEMBER 2006, PRIOR TO IMPLEMENTATION OF AN EXPIRATION DATE. IT IS KNOWN THAT PRODUCT PLACED IN OPEN STORAGE UNDER EXTENDED UV EXPOSURE CAN BECOME EMBRITTLED. FIELD EXPERIENCE SUGGESTED AT LEAST 5 YEARS EXPOSURE WAS REQUIRED TO CAUSE EMBRITTLEMENT. A 3 YEAR EXPIRATION DATE WAS SUBSEQUENTLY INSTITUTED PENDING COMPLETION OF UV LABORATORY TESTING.

    Description of Event or Problem · 1

    COMPLAINANT STATED THAT A 3000CC SUCTION LINER IMPLODED DURING A LIPOSUCTION. THERE WERE NO PT CONSEQUENCES. COMPLAINANT STATED COVER PORTION OF FLEXIBLE LINER IS BRITTLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BEMIS QUICK-FIT 3000CC SUCTION LINER APPARATUS, SUCTION, VACUUM POWERED KDQ BEMIS MFG. CO. 3004 20061222

    Patients

    Seq Age Sex Outcome Treatment
    1