Patient Problem
No Known Impact Or Consequence To Patient (2692)
Event Date 09/26/2012
Event Type
malfunction
Event Description
She stated that after a couple of nights, it came apart and lost its shape.She reboiled as the instructions indicate and she is disappointed it didn't last more than a couple of nights when the packaging says it should last 6 months.
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.