BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEMIS QUICK FIT 3000CC SUCTION LINER

    MDR report key: 1578314 · Received January 11, 2010

    Report

    Report Number
    2133713-2009-00009
    Event Type
    Malfunction
    Date Received
    January 11, 2010
    Date of Event
    December 28, 2009
    Report Date
    January 8, 2010
    Manufacturer
    BEMIS MFG. CO.
    Product Code
    KDQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LIKELY CAUSE IS EMBRITTLEMENT OF PLASTIC DUE TO EXCESSIVE UV EXPOSURE DURING STORAGE. SINCE JULY 2009, DIRECTIONS FOR USE INCLUDE A WARNING STATEMENT REGARDING IMPROPER STORAGE CONDITIONS.

    Description of Event or Problem · 1

    DURING A LIPOSUCTION PROCEDURE, FLEXIBLE SUCTION LINER COVER IMPLODED. THERE WERE NO PT CONSEQUENCES, AND NO INJURY TO CAREGIVER. 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 20061220

    Patients

    Seq Age Sex Outcome Treatment
    1