BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REBELO 5*350 TITANIUM

    MDR report key: 17214862 · Received June 28, 2023

    Report

    Report Number
    3007697975-2013-00001
    Event Type
    Malfunction
    Date Received
    June 28, 2023
    Date of Event
    December 6, 2013
    Report Date
    June 28, 2023
    Manufacturer
    EUROMI SA
    Product Code
    GEA
    PMA / PMN Number
    878.4800
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACP WAS CLOSED AS A RESULT OF INTERNAL ANALYSIS THAT DEMONSTRATES THAT THE INCIDENT IS NOT RELATED TO A MANUFACTURING ISSUE OR A PRODUCT QUALITY ISSUE. THE DEVICE HAD LARGELY EXCEEDED ITS LIFESPAN DURING THE INTERVENTION AND THE CONDITION OF THE CANNULA SHOWS VERY CLEARLY THAT IT HAD ALREADY BEEN USED A VERY LARGE NUMBER OF TIMES; SINCE THE OPENING OF THE FILE, GREAT DIFFICULTY IN OBTAINING INFORMATION FROM THE CUSTOMER. THIS IS A REBELO 5*350 TITANIUM CANNULA (REF: 1201LRET-5350). A UNIT SOLD ON 22/01/2010 - ONLY (B)(4) UNITS OF THE (B)(4) UNIT BATCH WERE SOLD, ALL OTHERS WERE DOWNGRADED FOLLOWING THE MANUFACTURE OF THE EUROMI CANNULAS AND THE FEW ASSOCIATED SALES. INITIAL DELAY IN REPORT SUBMISSION WAS DUE TO EMPLOYEE TURNOVER IN THE QUALITY DEPARTMENT, THIS REPEAT REPORT IS DUE TO THE FORMAT BEING UPDATED TO MEET THE ESG REQUIREMENTS.

    Description of Event or Problem · 0

    WHEN THE CANNULA WAS INSERTED INTO THE PATIENT'S BODY AT THE START OF A LIPOSUCTION PROCEDURE, IT BROKE AT THE BASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167652 REBELO 5*350 TITANIUM LIPOSUCTION SYSTEM CANNULA, REUSABLE GEA EUROMI SA REBELO 5*350 TITANIUM 1201LRET-5350

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other