On (b)(6) 2014, the following was reported to arjohuntleigh by the supply chain manager: 12 evolve mattresses are developing a depressed are in the center of the mattress.If this type of malfunction were to recur, it may cause or contribute to the serious injury or medical intervention to prevent harm.Therefore, this event is reportable.This is number 9 of 12 events for this facility.
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(b)(4).Please note that previous medwatch reports for this product may have been submitted from the mfr site kinetic concepts, inc (under registration # (b)(4)).As of (b)(4) 2012, complaints related to this product are to be handled by arjohuntleigh, inc and reg #(b)(4).Additional info will be provided upon conclusion of the mfr investigation.
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