Patient Problem
No Known Impact Or Consequence To Patient (2692)
Event Date 04/18/2014
Event Type
malfunction
Event Description
After 3 weeks of use, the two layers separated.
Manufacturer Narrative
This complaint has not been confirmed.Device not returned to manufacturer, and no lot number information was given so an evaluation cannot be performed as to the root cause or actual nature of the problem.No injury was reported, no medical attention was reported to have been sought.This is being reported as a possible delamination, as choking is possible as a result of delamination.