CANE, QUAD, SMALL BASE, BLACK

Description of Event or Problem

IT WAS REPORTED, "THE CANE BROKE IN HALF ON SATURDAY NIGHT AND SHE FELL, SHE IS ALL BRUISED AND ENDED UP IN THE EMERGENCY ROOM."

Additional Manufacturer Narrative

SUPPLEMENTAL DOCUMENTATION CHANGED/ADDITIONAL INFORMATION ADDED. G6 TYPE OF REPORT - FOLLOW-UP, 01. H2 IF FOLLOW-UP WHAT TYPE? ADDITIONAL INFORMATION. H6 TYPE OF INVESTIGATION- 4110, 4114. H5 INVESTIGATION CONCLUSION - ZCD00006/UNCONFIRMED DEFECT. H10 INVESTIGATION REPORT READS AS FOLLOWS: 07/26/2021 07:54:42 CST (B)(6). "COMPLAINT COULD NOT BE CONFIRMED, AS THERE WERE NO SAMPLES OR PICTURES RECEIVED. WITHOUT A SAMPLE RECEIVED, IT IS DIFFICULT TO DETERMINE A TRUE ROOT CAUSE FOR THE REPORTED ISSUE. THE DIVISION PERFORMS QUARTERLY TRENDING ON ALL COMPLAINTS RECEIVED, AND WILL INITIATE FURTHER INVESTIGATION AND/OR SUPPLIER CORRECTIVE ACTION REQUESTS BASED ON TRENDING RESULTS. SHOULD THE SAMPLE/DETAILED PICTURE BECOME AVAILABLE, WE WILL REOPEN THE COMPLAINT AND INVESTIGATE ACCORDINGLY."

Additional Manufacturer Narrative

IT WAS REPORTED, "THE CANE BROKE IN HALF ON SATURDAY NIGHT AND SHE FELL, SHE IS ALL BRUISED AND ENDED UP IN THE EMERGENCY ROOM." PHONE CALL PLACED TO END USER, WHO PROVIDED ADDITIONAL INFORMATION IN REGARDS TO THIS INCIDENT. END USER REPORTS THIS INCIDENT OCCURRED THIS PAST SUNDAY (B)(6) 2021 EARLY MORNING AT 2AM. END USER STATES, SHE HAD GOTTEN UP TO GO TO THE BATHROOM AND AS SHE WAS ENTERING THE BATHROOM DOORWAY HER CANE BROKE AND SHE FELL FORWARD INTO THE DOOR FRAME HITTING HER FOREHEAD. END USER REPORTS SHE "HAS TWO BLACK EYES, A LARGE KNOT ON HER FOREHEAD, HER RIGHT SIDE (ARM, LEG AND TORSO) ARE BRUISED." END USER STATES SHE HAS A CUT REPORTED TO BE A SKIN TEAR ON HER RIGHT THUMB. END USER STATES, HER HOME HEALTH NURSE CALLED AN AMBULANCE AND SHE WAS TAKEN TO (B)(6) HOSPITAL, IN (B)(6). END USER STATES, AT THE HOSPITAL BLOOD WORK, X-RAYS, AND MRI WERE COMPLETED. END USER REPORTS, ALL TESTS WERE NEGATIVE AND SHE WAS DISCHARGED FROM THE HOSPITAL THE FOLLOWING MORNING AT 3 AM, (B)(6) 2021. END USER REPORTS SHE TAKES A BLOOD THINNER DAILY (PLAVIX). END USER STATES, "THIS WHOLE THING HAS BEEN SUCH AN EXPERIENCE." END USER IS NOT WILLING AT THIS TIME TO RETURN THE CANE FOR TESTING AND EVALUATION HOWEVER, AGREES TO SEND PICTURES VIA MAIL (COMPUTER IS NOT WORKING AT PRESENT TIME). DUE TO THE REPORTED INCIDENT, MEDICAL INTERVENTION AND IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED, "THE CANE BROKE IN HALF ON SATURDAY NIGHT AND SHE FELL, SHE IS ALL BRUISED AND ENDED UP IN THE EMERGENCY ROOM."