Though no product was returned from the user facility in (b)(6), pictures were reviewed by a quality engineer and marketing specialist and the pictures did not appear to show a product malfunction.It was explained to the customer that the covers are loose to provide proper patient immersion and pressure redistribution as part of the therapeutic properties of the mattress.If a patient¿s skin has become marked from laying on the mattress, this may indicate improper hospital turning protocols or a pre-existing skin condition.
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