MAUDE Adverse Event Report: CARDINAL HEALTH SHANGHAI STEERABLE KNEE WALKER; WALKER, MECHANICAL

Model Number CWAL240KSR

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Fall (1848)

Event Date 11/25/2019

Event Type  Injury  

Manufacturer Narrative

The complaint was forwarded to the manufacturing facility where it is currently still under investigation.A follow-up report will be filed once the results have been completed.

Event Description

The customer previously had a reconstructive foot surgery for arch and heel requiring use of a steerable knee walker.This customer stated that the steerable knee walker cwal240ksr, lot 8400009636-sh-1902 had a defected steering handle and faulty brakes that allegedly caused him to be lodged off the walker three times.The pharmacy provided a second knee walker that the customer reported had a seat that was rippling and cracking where the knee rests and now he allegedly has inflammation in his right knee.A follow-up x-ray showed the arch is not healing correctly and the customer is concerned the altered healing is secondary to the defective knee walker.He reportedly complains of continued pain spikes from nerves, muscle tissue & bone tenderness where he was prescribed oxycodone 10mg.

Manufacturer Narrative

Mdr supplemental report is being filed since the results of investigation are available.Based on the supplier investigation, the device history record for the steerable knee walker (b)(6), lot# 8400009636-sh-1902 showed no exception or abnormal situation that could lead to the reported incident.After checking the device history record for the first knee walker, there was no history of this incident occurring and no abnormalities had been detected during production and inspection.After reviewing the device master record, there was no change in the design, production process or related materials for all rollators.The handle of the walker is a rubber grip with pits distributed on the surface for better gripping in use.The knee walker uses the right brake handle.The brake cable connects the handle to the rear wheel brake pads.User can use the right brake handle to brake the knee walker.In addition, the brake handle has a fixed brake button.User can alternatively use the fixed brake function.The user puts one knee on the seat cushion to walk with the knee walker, and adjusts seat cushion to appropriate height according to user¿s height.No matter in walking or at rest with the knee walker, user should keep upright.It cannot be determined if the customer being lodged off from knee walker has direct relationship with the brake without a sample.The knee walker¿s brake consists of components as brake handle, brake cable, brake adjustment knob, and brake connecting pad.The brake¿s tightness can be adjusted.There are two position for adjusting brake tightness, which are located on the two end of brake cable.When the brake is too tight or too loose, it can manually be adjusted.This knee walker also has a fixed brake button on the brake handle.Pressing this fixed button to brake without continue holding the brake handle.The brake of the knee walker will be locked and not be able to move anymore.When user needs to move with the knee walker, they only need to operate the right handle, then the fixed brake button will spring up automatically, then the walker can move.We cannot assess how the user operated the brake.The failure could not be confirmed and the root cause could not be determined from this investigation with limited complaint information and no sample available for investigation.After checking the device history record for the second knee walker, there was no history of this incident occurring and no abnormalities had been detected during production and inspection.After reviewing the device master record, there was no change in the design, production process or related materials for all rollators.The knee walker is equipped with a soft pad.When user's knee placed on the pad, the soft cushion has a function to ease the vibration and assist user in walking.We cannot assess if the knee inflammation of customer has direct relationship to soft pad of knee walker.The complaint information was informed to the relevant sectors for their awareness.There is no additional action taken at this time.

Manufacturer Narrative

Supplemental report is being filed since a photo allegedly of the steerable knee walker cwal240ksr, lot 8400009636-sh-1902 was provided after the previous supplemental report was filed.From the complaint photo, the investigation analysis is as follows: 1) we cannot determine from the photos provided which knee walker this is.2) the overall components of the knee walker are complete without obvious deformation or breakage.3) the seat adjusting tube is locked with a fixed knob, indicating that the structure of the seat fixing device is normal.4) the position of the folding buckle of the front and rear main bodies is complete, and there are no abnormalities in the components of the quick assembly handle, indicating that the structure and function of both parts are also normal.5) there is a fixed knob locked on the adjustment tube of the handle on the front body without significantly abnormality.6) the surface of the 4 wheels can be seen with obvious white circle marks, indicating that the 4 wheels can move normally.There are no obvious brake friction traces, the brake does not affect the normal rotation of the wheels.7)the handle of the walker is complete with all components.No obvious deformation or damage.8) the lock button on the brake handlebar and the brake tightness adjustment device are complete without obvious abnormalities on appearance.The complaint information was informed to the relevant sectors for their awareness.There is no additional action taken at this time.

• Brand Name: STEERABLE KNEE WALKER
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): CARDINAL HEALTH SHANGHAI; f20, tower 1, kerry everbright; shanghai 20007 0; CH 200070
• MDR Report Key: 9522107
• MDR Text Key: 189051327
• Report Number: 1423537-2019-00388
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CWAL240KSR
• Device Catalogue Number: CWAL240KSR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/25/2019
• Event Location: Home
• Initial Date Manufacturer Received: 11/25/2019
• Initial Date FDA Received: 12/26/2019
• Supplement Dates Manufacturer Received: 11/25/2019; 11/25/2019
• Supplement Dates FDA Received: 01/02/2020; 03/30/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR
• Patient Weight: 122