Patient Problem
No Known Impact Or Consequence To Patient (2692)
Event Date 12/12/2012
Event Type
malfunction
Event Description
Consumer called in to us to complain he really likes it because it is comfortable for him.He thought that it was maybe a fluke but it actually separates into the two pieces has begun to separate.He takes them back to rite aid and they have been great about returning the product.He did not need a replacement, already resolved with retailer.
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.