End-user reported having been battling a recurring pressure ulcer which had started to develop on their back, just above the coccyx region, for approximately 3 weeks.Over that time the ulcer has reportedly grown to stage 3 and requires surgery to address.The end-user reported having home health aides help diagnose the possible cause and they speculated it was from the compression of the foam on the back cushion allowing the zippers that attach the cushion cover to press through and create a pressure point.Photos of the cushion (taken by the end-user) appear to depict indentations in the foam material where the zippers terminate, but not to the point of diminishment of the foam material.Inquiries made to the end-users therapist indicate they found the roho seat cushion had been under inflated which changed the end-users positioning, potentially forcing the end-user to apply more pressure on their lower back, thus compressing the foam material.Review of device history and analysis of complaint data indicate no other reports of this nature have been received by permobil.Permobil is unable to confirm a product malfunction occurred to have caused this reported event, thus are unable to reach a determination as to root cause without speculation.The dhr was reviewed, and device was found to have met specification prior to distribution.
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