Patient Problem
No Known Impact Or Consequence To Patient (2692)
Event Date 01/27/2014
Event Type
malfunction
Event Description
Consumer purchased the guard around (b)(6) and he just opened it and when he used it and followed the directions, the product fell apart.He placed it in hot water for 30 seconds and that's when it fell apart.
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.