BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURLIN

    MDR report key: 1203668 · Received October 9, 2008

    Report

    Report Number
    2031921-2008-00049
    Event Type
    Malfunction
    Date Received
    October 9, 2008
    Date of Event
    July 11, 2008
    Report Date
    October 8, 2008
    Manufacturer
    CURLIN MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER WAS CONTACTED TO OBTAIN MORE INFO BUT STATED THAT IT WAS UNK AS TO WHERE OR HOW THE LEAKAGE OCCURRED. THE DEVICE WAS NOT RETURNED FOR EVAL AND WITH THE LIMITED INFO PROVIDED NO CONCLUSIONS COULD BE DRAWN.

    Description of Event or Problem · 1

    CURLIN MEDICAL WAS INFORMED OF A REPORTABLE EVENT IN 2008 BY A DISTRIBUTOR. IT WAS REPORTED THE SAME DAY THAT A PT RECEIVED A ADMINISTRATION SET EXPLODED AND SPLIT. NO PT INJURY OCCURRED AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURLIN CURLIN ADMINISTRATION SET FPA CURLIN MEDICAL, INC. 340-4130-V UNK

    Patients

    Seq Age Sex Outcome Treatment
    1