Description of Event or Problem · 0
THE PATIENT WAS PRESCRIBED A PD32-G3 PNEUMATIC COMPRESSION DEVICE FOR TREATMENT OF LOWER EXTREMITY LYMPHEDEMA AND RECEIVED THE DEVICE ON (B)(6) 2021. ON (B)(6) 2024, THE PATIENT CONTACTED TACTILE MEDICAL AND SPOKE WITH CLINICAL PATIENT SERVICES REPORTING THE HOSE ON THE LEFT LEG GARMENT CAUSED A LARGE WOUND. HE STATED THAT HE HAD NOT USED THE DEVICE BETWEEN 2021, AFTER INITIALLY RECEIVING THE DEVICE, AND ON (B)(6) 2024. NO REASON WAS GIVEN FOR THE PAUSE IN USAGE. THOUGH DURING THIS TIME, HE HAD VARIOUS VASCULAR PROCEDURES AND A RIGHT LEG AMPUTATION. WITH CLEARANCE AND OVERSIGHT OF HIS TREATING CLINICIAN, THE PATIENT RESUMED USE OF DEVICE ON (B)(6) 2024, THREE TIMES PER WEEK WITH ASSISTANCE OF A HOME HEALTH AIDE. HE HAD SEVERAL COMORBIDITIES INCLUDING WOUNDS, HEEL TRAUMA, AND DVT OF LEFT LOWER EXTREMITY BEING MEDICALLY MANAGED. A HOME HEALTH AIDE ASSISTED WITH DEVICE USAGE AND APPLICATION OF GARMENT, WHICH PATIENT NOTED THEY FELT WAS BEING WRAPPED TIGHTLY, OVER TWO-LAYER BANDAGING, FOAM PADDING AND KOBAN FROM TOES TO KNEE ON LEFT LEG. DUE TO PARAPLEGIA, THE LEFT LEG EXTERNALLY ROTATED TOWARD THE HOSES WITHIN THE GARMENT. THE PATIENT REPORTED HE HAS NO SENSATION IN HIS LEFT LEG, THUS WAS UNABLE TO FEEL ANY PAIN OR DISCOMFORT. OVER THE COURSE OF APPROXIMATELY SIX WEEKS OF DEVICE USE, THE PATIENT'S WOUND CARE NURSE NOTED SKIN CHANGES FROM REDNESS, TO WEEPING, FOLLOWED BY SKIN BREAKDOWN, AND WORSENING OF CONDITION WHICH LED THEM TO CONTACT THE PATIENT'S HEALTH CARE TEAM ON (B)(6) 2024. THE PATIENT WAS ADVISED TO STOP DEVICE USE FOR THE TIME BEING. THE PATIENT'S HEALTH CARE TEAM SUBSEQUENTLY PERFORMED DEBRIDEMENT OF THE WOUND TO IMPROVE RECOVERY. TACTILE MEDICAL'S CHIEF MEDICAL OFFICER REVIEWED THE REPORTED EVENT ON 11/15/2024, CONCLUDING THE TUBING LOCATION ON THE GARMENT AND THE PATIENT'S LIMB WEIGHTBEARING ONTO THE TUBING WITHOUT LEG SENSATION WAS LIKELY A CONTRIBUTORY FACTOR TO WOUND/SKIN BREAKDOWN OF LATERAL LOWER LEFT LEG. THE PATIENT HAS SINCE BEEN GIVEN CLEARANCE FROM HIS CLINICIAN TO RESUME TREATMENT WITH DEVICE AND DAILY COMPRESSION FOR MANAGEMENT OF LYMPHEDEMA AND WOUNDS.