STEERABLE KNEE WALKER
Received Apr 10, 2018 · Event occurred Mar 23, 2018
Report 1423537-2018-00176 · MDR key 7418677
Device
Generic name
Walker, Mechanical
Manufacturer
Jan Mao Industries Co. Ltd.Model number
CWAL240KSRCatalog number
CWAL240KSR
Lot number
20161030-SH-R
Product problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
Patient
Not reported
- Fall
- Fall
Narrative
Additional Manufacturer Narrative
BASED ON THE SUPPLIER¿S INVESTIGATION, THE DEVICE HISTORY RECORD REVIEW FOR THE REPORTED LOT NUMBER DID NOT INDICATE ANY EXCEPTION THAT COULD LEAD TO THE REPORTED INCIDENT. AS THE DEVICE WAS NOT RETURNED FOR FURTHER INVESTIGATION, THE ROOT CAUSE COULD NOT BE DETERMINED FROM THIS INVESTIGATION. THE COMPLAINT INFORMATION WAS PROVIDED TO THE RELEVANT SECTORS FOR THEIR AWARENESS. THERE IS NO ADDITIONAL ACTION TAKEN AT THIS TIME, BUT THE SUPPLIER WILL CONTINUE TO MONITOR THE TREND OF THIS TYPE OF INCIDENT.
Description of Event or Problem
THE CUSTOMER CALLED AND STATED THAT THE RUBBER CAME OFF THE WHEEL OF THE STEERABLE KNEE WALKER WHILE HIS WIFE WAS ON IT. SHE ALLEGEDLY FLIPPED OVER THE WALKER, SCRAPED HER KNEE A LITTLE AND BRUISED HERSELF. REPORTEDLY SHE WENT TO THE DOCTOR AND RECEIVED A CORTISONE SHOT.