Patient Problem
No Known Impact Or Consequence To Patient (2692)
Event Date 11/26/2012
Event Type
malfunction
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.
Event Description
Customer mailed in the survey to complain the fit of the protector was okay, but the bottom hard plastic mold separated from the top soft plastic.Now the mouthguard is unwearable.I would like a refund please, not a replacement.