VECTRA GENISYS 2 CH

Description of Event or Problem

PATIENT ARRIVED FOR HER 4:00PM PHYSICAL THERAPY TREATMENT APPOINTMENT. WHILE ON THE SCI-FIT SEATED STEPPER, PATIENT INFORMED PHYSICAL THERAPIST OF SUPERFICIAL WOUND ON HER L LOWER BACK/FLANK AREA THAT SHE AND HER SON NOTICED LATE THAT EVENING A FEW DAYS EARLIER. PATIENT AND SON REPORTED THAT AFTER PHYSICAL THERAPY THAT DAY (~6PM), THEY WENT DO SOME ERRANDS AND WENT HOME AND NOTICED THE LOCALIZED DISCOLORED AREA ON L LOWER BACK/FLANK. THE PATIENT'S SON STATES THEY PUT NEOSPORIN ON IT AND IT SEEMS TO HAVE SCABBED OVER ON THE WEEKEND; PT DENIED PAIN ON OR AROUND THE SAME AREA THROUGHOUT THE WEEKEND. UPON INSPECTION, THE PHYSICAL THERAPIST NOTED A 1.0 INCH BY 0.5 INCH OVAL SHAPED WOUND WITH CLEAN EDGES AND BLACK SLOUGH, (-) DRAINAGE, (-) ERYTHEMA ON LEFT LOWER BACK/FLANK REGION. PT DENIED PAIN ON WOUND OR PERIPHERY UPON OCULAR INSPECTION AND PALPATION AROUND THE LOWER BACK REGION. REVIEW SHOWED IT IS APPROXIMATELY AROUND THE AREA WHERE THE ELECTRODE PADS FOR THE INTERFERENTIAL CURRENT MODALITY WAS PLACED ON PT'S LAST TREATMENT. PHYSICAL THERAPIST CALLED REHAB MANAGER TO INFORM HER OF INCIDENT. REHAB MANAGER ARRIVED AND INSPECTED THE AREA AS WELL AS INTERVIEWED THE PATIENT AND SON ABOUT THE INCIDENT. MANUFACTURER RESPONSE FOR ELECTRICAL STIMULATOR MACHINE, VECTRA GENISYS (PER SITE REPORTER): REPORTED BY MGR OF REHAB. MANUFACTURER ESCALATED THE EVENT TO THE REGIONAL MGR. CURRENTLY AWAITING RESPONSE.

Description of Event or Problem

PATIENT ARRIVED FOR HER 4:00PM PHYSICAL THERAPY TREATMENT APPOINTMENT. WHILE ON THE SCI-FIT SEATED STEPPER, PATIENT INFORMED PHYSICAL THERAPIST OF SUPERFICIAL WOUND ON HER L LOWER BACK/FLANK AREA THAT SHE AND HER SON NOTICED LATE THAT EVENING A FEW DAYS EARLIER. PATIENT AND SON REPORTED THAT AFTER PHYSICAL THERAPY THAT DAY (~6PM), THEY WENT TO DO SOME ERRANDS AND WENT HOME AND NOTICED THE LOCALIZED DISCOLORED AREA ON L LOWER BACK/FLANK. THE PATIENT'S SON STATES THEY PUT NEOSPORIN ON IT AND IT SEEMS TO HAVE SCABBED OVER ON THE WEEKEND; PT DENIED PAIN ON OR AROUND THE SAME AREA THROUGHOUT THE WEEKEND. UPON INSPECTION, THE PHYSICAL THERAPIST NOTED A 1.0 INCH BY 0.5 INCH OVAL SHAPED WOUND WITH CLEAN EDGES AND BLACK SLOUGH, (-) DRAINAGE, (-) ERYTHEMA ON LEFT LOWER BACK/FLANK REGION. PT DENIED PAIN ON WOUND OR PERIPHERY UPON OCULAR INSPECTION AND PALPATION AROUND THE LOWER BACK REGION. REVIEW SHOWED IT IS APPROXIMATELY AROUND THE AREA WHERE THE ELECTRODE PADS FOR THE INTERFERENTIAL CURRENT MODALITY WAS PLACED ON PT'S LAST TREATMENT. PHYSICAL THERAPIST CALLED REHAB MANAGER TO INFORM HER OF INCIDENT. REHAB MANAGER ARRIVED AND INSPECTED THE AREA AS WELL AS INTERVIEWED THE PATIENT AND SON ABOUT THE INCIDENT. MANUFACTURER RESPONSE FOR ELECTRICAL STIMULATOR MACHINE, VECTRA GENISYS (PER SITE REPORTER). REPORTED BY MGR OF REHAB. MANUFACTURER ESCALATED THE EVENT TO THE REGIONAL MGR. ¿ CURRENTLY AWAITING RESPONSE.