EQUATE

Description of Event or Problem

UPDATED BEING MADE TO AWARENESS DATE.

Description of Event or Problem

THE DEVICE BENT DURING USE AND THE END USER FELL. THE END USER BEING TREATED FOR A CONCUSSION FROM THE FALL. THE END USER HAS DIZZINESS FROM THE CONCUSSION. THE END USER GOES TO THERAPY TO HELP WITH BALANCE.

Additional Manufacturer Narrative

DEVICE WAS EVALUATED BY IMPORTER ON 03/20/2025. THE CANE WAS ABLE TO BE ASSEMBLED AND ADJUSTED TO ANY HEIGHT THAT WAS JUST BELOW THE BEND IN THE FRAME. THERE IS BLACK TAPE WRAPPED AROUND THE HANDLE/GRIP OF THE CANE. ONE OF THE EDGES WAS SIGNIFICANTLY MORE WORN DOWN THAN ANY OF THE OTHER THREE TIPS. THE SIGNIFICANT WEAR AND TEAR TO ONE OF THE CANE TIPS COULD HAVE POSSIBLY CONTRIBUTED TO AN UNSTABLE CANE ONCE WEIGHT WAS APPLIED, IF THE TIP WAS DEFORMED BEFORE THE INCIDENT. IT IS IMPORTANT TO NOTE, HOWEVER, IT IS UNKNOWN AT THIS TIME WHETHER THE TIP WAS DEFORMED BEFOREHAND OR IF THE DEFORMATION OF THE CANE TIP RESULTED FROM THE INCIDENT. AS RECOMMENDED IN THE USER GUIDE, CANE TIPS SHOULD BE REPLACED AS SOON POSSIBLE ONCE ANY WEAR AND TEAR IS NOTICED. IT IS ALSO UNKNOWN AT THIS TIME WHETHER THE END USER LEVERAGED THEIR FULL BODY WEIGHT ON TO THE DEVICE, CONTRIBUTING TO THE INCIDENT. THE USER GUIDE STATES THAT FULL BODY WEIGHT SHOULD NOT BE APPLIED TO DEVICE. WE ARE UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THIS INCIDENT.