Description of Event or Problem · 1
RPTR RECENTLY UNDERWENT SURGERY. A REP OF CO SOLD RPTR A SET OF "FOREARM CRUTCHES TALL ADULT." REP MERELY GAVE THE CRUTCHES AND MATCHED THEIR HEIGHT TO THE ONES RPTR WAS USING. NO FURTHER INSTRUCTIONS WERE GIVEN. OVER THE NEXT TEN DAYS, RPTR HAD THREE SUDDEN FAILURES OF THE CRUTCHES. THE PROBLEM APPEARS TO BE DUE TO THE BRASS COLORED ADJUSTING PIN RETRACTING INTO THE ADJUSTMENT HOLE, LEAVING NO SUPPORT FOR THE WEARER. THERE ARE RIDGED SAFETY TIGHTENING DEVICES ON THE CRUTCHES. ALTHOUGH NO ONE HAD INSTRUCTED RPTR IN THEIR USE, RPTR REALIZED WHAT THEY WERE AND HAND TIGHTENED THEM BEFORE RPTR USED. THIS DID NOT PREVENT THE FIRST FAILURE. RPTR THEREUPON USED PLIERS TO TIGHTEN THEM. THIS DID NOT PREVENT THE SECOND AND THIRD FAILURES. RPTR NOW INSPECTS THE CRUTCHES PRIOR TO EACH USE TO VERIFY THAT THE PINS ARE FULLY EXTENDED. ON TWO ADDITIONAL OCCASIONS THEY WERE NOT. IT IS RPTR'S BELIEF THAT THE CRUTCHES SUPPLIED CONSTITUTE A "MEDICAL DEVICE" AS DEFINED BY THE U.S. FOOD AND DRUG ACT. ACCORDINGLY RPTR IS SUBMITTING A MEDWATCH REPORT TO THE FDA. HOWEVER, RPTR HAS A PROBLEM, THERE IS NO MFR'S IDENTITY ON THE CRUTCHES, ONLY AN INSPECTION AND SERIAL NUMBER. FURTHERMORE, RPTR IS NOTIFYING BOTH HOSPITAL AND THE DEPARTMENT OF HEALTH THAT CO IS SUPPLYING APPARENTLY DEFECTIVE MEDICAL EQUIPMENT. RPTR STRONGLY SUGGESTS THAT CO NOTIFY ALL CONSUMERS OF THIS ITEM, OF THIS DEFECT AS WELL AS A WARNING TO INSPECT THE CRUTCH PINS PRIOR TO EACH USE. RPTR HAS ALREADY PAID FOR THIS ITEM.