Patient Problem
No Known Impact Or Consequence To Patient (2692)
Event Date 04/15/2014
Event Type
malfunction
Event Description
This is the second time i purchased this product and both times the two layers separated from each within the first week of wearing.Do you have any remedies for this problem?.
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.