The end-user had contacted the dealer reporting the injury having occurred the day following initial delivery and set-up.It was reported that after the dealer had left, the end-user remained in the device but did not utilize the stand function.That evening while being transferred out of device and into bed, it was reported their left knee was swollen and was painful.The following day after noting the swelling in the knee had not subsided, they were taken to the hospital for evaluation.X-ray's were reported to indicate a fracture having occurred at the lower part of the left femur, just above the patella.The permobil territory manager and dealer, both of which were present at initial delivery, report the end-user never made mention of being uncomfortable or being in pain during the set up process.Territory manager reported after having covered operational characteristics of the device and setting seating for client positioning, an initial stand function was performed.Approximately half way into the initial stand sequence, it was noted the kneeblock assembly was getting tight against the end-users legs and their lower body had shifted to the side of the seating.When this was noticed, the end-user was informed to stop the stand sequence and lower the seating to a sitting position in order to make minor adjustments for proper positioning.After adjustments had been made, further stand sequences were performed all the while watching the end-users positioning and inquiring as to their physical well-being to which they claimed felling great.It is unclear as to when the reported injury may have occurred.The device is fully operational and remains in the end-user possession for mobility, but they are not using the stand function until having healed from the injury and receiving approval from their physician to resume standing therapy.The dhr was reviewed and the device met specification prior to distribution.
|