BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIODYNAMICS

    MDR report key: 3066255 · Received April 15, 2013

    Report

    Report Number
    MW5029790
    Event Type
    Injury
    Date Received
    April 15, 2013
    Date of Event
    November 9, 2010
    Report Date
    April 5, 2013
    Manufacturer
    ANGIODYNAMICS
    Product Code
    MSD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURAFLOW PLACEMENT (B)(6) 2010. RETURNED FOR CATHETER CRACKED (B)(6) 2010. REPLACED CATHETER. NO LOT NUMBER AVAILABLE. (B)(6) MALE WITH CYSTIC FIBROSIS STATUS POST BILATERAL LUNG TRANSPLANT AND RENAL TRANSPLANT NOW WITH END-STAGE RENAL DISEASE REQUIRING DIALYSIS. THE DURAFLOW CATHETER PLACED ON (B)(6) 2010 HAS BECOME CRACKED. INTERVENTIONAL RADIOLOGY IS CONSULTED FOR EXCHANGE OF THE DURAFLOW CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160429 ANGIODYNAMICS DURAFLOW MSD ANGIODYNAMICS

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention