MAUDE Adverse Event Report: JAN MAO INDUSTRIES CO. LTD. STEERABLE KNEE WALKER; WALKER, MECHANICAL

Model Number CWAL240KSR

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Fall (1848)

Event Date 03/23/2018

Event Type  Injury  

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.

Event Description

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.

• Brand Name: STEERABLE KNEE WALKER
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): JAN MAO INDUSTRIES CO. LTD.; gong ting village, first indus; long xi town bo luo hsing; hiu zhou city,gong dong provid 51612 1; CH 516121
• Manufacturer (Section G): JAN MAO INDUSTRIES CO. LTD.; gong ting village, first indus; long xi town bo luo hsing; hiu zhou city,gong dong provid 51612 1; CH 516121
• Manufacturer Contact: patricia tucker ; 1500 waukegan rd; waukegan, IL 60085
• MDR Report Key: 7418677
• MDR Text Key: 105138805
• Report Number: 1423537-2018-00176
• 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
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/26/2018,04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CWAL240KSR
• Device Catalogue Number: CWAL240KSR
• Device Lot Number: 20161030-SH-R
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/23/2018
• Device Age: 3 MO
• Date Report to Manufacturer: 03/26/2018
• Date Manufacturer Received: 03/23/2018
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other