Description of Event or Problem · 1
THIS TYPE OF CANE IS TOO EASY TO BEND WHEN BODY WEIGHT WAS PUT ON IT. COULD NOT SUSTAIN AMOUNT OF PRESSURE PUT ON IT FOR PTS TO WALK SAFELY. THE TIP WOULD COME OFF IF CAUGHT ON THE EDGE OF STAIRWAY OR CURB. SOME TIPS FELL OFF WITHOUT OUTSIDE FORCE APPLIED. PT SAFETY IS A DEFINITE FOCUS. ON THE BASIS OF DEPOT'S INVESTIGATION, THE FOLLOWING INFO IS PROVIDED: 1. INVESTIGATION FINDINGS: DEPOT WAS REC'D THREE SIMILAR COMPLAINTS BETWEEN JANUARY AND DECEMBER, 1997. THE FIRST, CITED NO CONTRACTOR/MFR OR PART NUMBER BUT WAS ACCOMPANIED BY A LETTER TO RUBBERMAID IN STATESVILLE, NC. THE SECOND COMPLAINT, A CREDIT CARD PURCHASE FROM CONTRACTOR, MOORE MED, LISTED CAREX HEALTH CARE PRODUCTS, STATESVILLE, NC AS THE MFR AND ALSO RUBBERMAID, INC IN NEWARK, NJ. IT CITED MODEL NUMBER AS A7100 . THE THIRD, CITED THE MFR AS MOORE MED, NEW BRITTAIN, CT BUT SENT IN SAMPLE LABELED: "RUBBERMAID A71100 WOODEN CANE WALNUT FINISH MADE IN USA CAREX HEALTH CARE PRODUCTS STATESVILLE, NC." DEPOT HAS CONCLUDED THAT THE SUBJECT CANES FROM ALL OF THE COMPLAINTS WERE MADE BY THE SAME MFR. CAREX HAS APPARENTLY BEEN ACQUIRED BY RUBBERMAID WHO HAS MOVED THEIR OPERATIONS TO WINCHESTER, VA. MOORE MED WAS THE DIST IN AT LEAST TWO OF REPORTS. THE ABOVE NSN IS PROCURED FOR CENTRAL STOCK AND DIST THROUGH THE SYS UNDER SPECS WHICH CALL FOR THE CANE TO BE 1" IN DIAMETER, +/-1/8. THE SPECS FOR RUBBERMAID CANES CALL THE A DIAMETER OF 7/8" +/-1/32. EXAMINATION OF THE RUBBERMAID SAMPLES FOUND THE DIAMETER TO BE SLIGHTLY BELOW TOLERANCE. THIS IS APPARENTLY WHY THE TIP COMES OFF EASILY. "THE FDA TESTED SAMPLES FROM THE EARLIER COMPLAINTS AND CONCLUDED THAT THEY DEFORMED WITH A LOAD FORCE OF 215 TO 291 POUNDS BEFORE BREAKING. THE SPECS FOR THE NSN DOES NOT INDICATE A BREAKING FORCE." 2. ACTIONS TAKEN TO CORRECT EXISTING DEFICIENCY: THE FDA AND THE MFR HAVE BEEN ADVISED OF INITIAL COMPLAINT. SAMPLES WERE REQUESTED AND REC'D BY THIS CENTER. 3. ACTION TAKEN TO PRECLUDE RECURRENCE: DEPOT HAS ISSUED A QA REPORT.