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Thread: Defective Suprapubic Catheter

  1. #11
    Also, you can report adverse events directly to the FDA - It has been my experience that manufacturers are fairly rapidly responsive to correspondence containing or referencing an event report.

  2. #12

  3. #13
    Senior Member dnvrdave's Avatar
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    Feb 2002
    Denver, Colorado USA ---- C5/6 Complete 1985
    Great tips! I just made a video and submitted a report to the FDA. Next I will write to the CEOs of Medtronic and Edgepark and send them the report and a link to the video.

    What I discovered is that there is a blockage at the top, where the insertion tube joins with the catheter, and it is slightly less blocked when the balloon is deflated.

    "Cherish your tears. If you can cry, you still have some humanity left, and you are reclaiming more of it." -- David Kelly

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