A permobil representative had received a report of an end-user who had come to a scheduled appointment at a local wound care clinic in (b)(6) of 2019.Reports claim when the user arrived, the therapist noticed a wetness permeating through the end-user's left pant leg.Upon lifting the garment to inspect, they noted seeing a severe wound on the upper portion of their left tibia.The therapist described the wound as being a stage 4 pressure ulcer.Reports provided claim the most logical cause for this ulcer was the pressure induced to the leg, by the knee block assembly, when the end-user utilized the stand function of their device.The therapist described the pad as being very worn and thin to where it was no longer providing any further cushioning.Reports claim the end-user was instructed to refrain from using the stand feature any further until his wound could heal and appropriate padding can be ordered and installed to better support his physical needs.The therapist reported having seen the end-user multiple times since initial awareness and claims the end-user's wound had completely healed approximately 3-4 weeks afterwards.Records confirm an order having been placed for custom knee block inserts at the timeframe this event was reported to have occurred, but permobil was not made aware at that time that an injury had occurred.Due to the 2-year timespan from the occurrence to when permobil was notified, an inspection of the original knee pads could not be performed as they were disposed of, therefore permobil is unable to reach a determination as to possible root cause without speculation.The dhr was reviewed and the device was found to have met specification prior to distribution.
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