Description of Event or Problem · 1
MR LB REPORTED THAT HE HAD ATTENDED 2 OR 3 SESSIONS ON THE LOKOMAT AND HAD DEVELOPED SERIOUS GRADE 4 PRESSURE ULCERS AS A RESULT. PRELIMINARY NOTE: THE PATIENT USUALLY LIVES IN A DIFFERENT PART OF THE WORLD WHERE HE DOES HIS REGULAR LOKOMAT TRAINING SESSIONS 3 TIMES A WEEK FOR 1 HOUR. NO ADVERSE EVENTS HAVE HAPPENED DURING THESE REGULAR SESSIONS. FOR THE TIME THE PATIENT SPENT IN L., HE REFERRED TO AN OUTPATIENT DEPARTMENT TO CONTINUE HIS REGULAR TRAINING SESSIONS WITH THE DEVICE IN PLACE. THREE LOKOMAT TRAINING SESSIONS WERE CONDUCTED IN THE ABOVE-MENTIONED OUTPATIENT DEPARTMENT: - (B)(6) 2017: INITIAL ASSESSMENT. - (B)(6) 2017 50 MIN LOKOMAT TRAINING. - (B)(6) 2017 17 MIN LOKOMAT TRAINING. THE PATIENT REPORTED TO THE INITIAL REPORTER THAT HE HAD ATTENDED AN INITIAL APPOINTMENT FOR ASSESSMENT AND HAD THEN AGREED TO ATTEND THE [2ND] TRAINING SESSION. HE REPORTED THAT HE ATTENDED THE TRAINING SESSION WHICH WAS AROUND AN HOUR WHICH IS NO MORE THAN HE NORMALLY DOES AT HOME AND THAT THE THIRD SESSION WAS MUCH SHORTER. MR LB REPORTED THAT FOLLOWING THE TRAINING SESSION, HIS NURSE HAD NOTICED 2 SMALL "BRUISES" ON HIS BUTTOCKS AND THAT HE WENT TO SEE HIS GP WHO DID NOT THINK THERE WAS ANYTHING WRONG. HE THEN ATTENDED HIS THIRD LOKOMAT SESSION WITH THE THERAPIST AND REPORTED THE PRESSURE PROBLEMS ON THE ANKLES. MR LB REPORTED THAT UNBEKNOWN TO HIM OR US THERE WAS TISSUE DAMAGE BENEATH THE SMALL BRUISED AREA THAT HE FEELS MUST HAVE BEEN CAUSED DURING THE TRAINING SESSION EITHER BY THE STRAPS BEING TOO TIGHT OR TOO LOOSE OR THE PADDING NOT BEING IN PLACE.