OtherNXQ

JON + ALERT

Received Mar 10, 2014 · Event occurred Mar 7, 2014

Report MW5034908 · MDR key 3677423

Device

Generic name

Jon + Alert

Manufacturer

Medtronic Systems, Inc.

Product problems

Structural Problem

Patient

Not reported

No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

I'M LOOKING TO FIND OUT IF AN ACTIVELY LOCKED/ UNLOCKED, REMAINDERED PULL DISPENSING SYSTEM SHOULD BE FDA CONTROLLED. I HAVE CONCERNS THAT FLAWS IN THE DESIGN, IF IT WERE NOT APPROVED BY THE FDA, COULD RESULT IN PT HARM (NO PILLS, TOO MANY PILLS, ETC).