The wording in this 8k says "breakage of fiber" which has me wondering if this is a design, manufacture, or handling issue. If sub-standard fibers were being used in the manufacture this could be on medica. If they are being assembled to spec and fibers are breaking during transport/handling then any product based on these fragile fibers does not seem viable in my opinion and metuchen's grave prognostications may be accurate. Are these same fibers the heart of the design of the IWTD's??? IF they are the same fibers and are too brittle/fragile to withstand the type of abuse they receive during their lifecycle in a POU application how could they survive a war zone? Has anyone seen or handled these fibers? Are they/pliable or more glass like?
The filter failed and an infant died. The FDA called them out for advertising their POUs as medical devices. The liability is endless. They will fizzle out like a fart. They will never sell their products again.