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Model Number REST ASSURED, GEN II ORIGINAL |
Device Problems
Detachment Of Device Component (1104); Material Disintegration (1177); Malposition of Device (2616)
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Patient Problem
Complaint, Ill-Defined (2331)
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Event Date 11/24/2014 |
Event Type
malfunction
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Event Description
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Consumer stated he bought the guard months ago and is finally using it.The instructions were clear and he has fitted this type of guard before.He had to re-boil this one an extra time because the initial fit cooled before he got a good impression.Upon the 2nd attempt, the front part of the hard material disintegrated, but the impression was ok.He had to trim back the ends multiple time due to very sharp corners that dug in while he slept.After about 2 weeks the soft material started to detach from the hard material.
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Manufacturer Narrative
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Consumer stated he bought the guard months ago and is finally using it.The instructions were clear and he has fitted this type of guard before.He had to re-boil this one an extra time because the initial fit cooled before he got a good impression.Upon the 2nd attempt, the front part of the hard material disintegrated, but the impression was ok.He had to trim back the ends multiple time due to very sharp corners that dug in while he slept.After about 2 weeks the soft material started to detach from the hard material.
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Search Alerts/Recalls
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