OTTOBOCK HARMONY® P4 HD MECHANICAL PUMP

Description of Event or Problem

AS REPORTED BY THE PRESCRIBING / FITTING PRACTITIONER ((B)(6)), "WE RECENTLY HAD A PATIENT BEING FIT WITH A P4 PUMP. DURING THE TEST FIT PHASE, OUR TECHNICIANS HAD SCRATCHED UP THE TOP OF THE MOUNTING PLATE IN ORDER TO GIVE IT MORE BONDING SURFACE AREA. THE MOUNTING PLATE WAS ATTACHED TO THE SOCKET USING FAB TEC TWO PART RESIN. THEN THE PLATE AND SOCKET WERE BONDED TOGETHER WITH FIBERGLASS WRAP. THE PATIENT LEFT OUR FACILITY AND LATER THAT NIGHT THE MOUNTING PLATE COMPLETELY SEPARATED FROM THE SOCKET. UNFORTUNATELY, THE PATIENT FELL AND DISLOCATED HIS SHOULDER."