MAUDE Adverse Event Report: LINKOU MEDICAL INDUSTRIAL CO. LTD. FREE SPIRIT KNEE WALKER

Model Number P4000

Device Problems Inadequate Service (1564); Maintenance Does Not Comply To Manufacturers Recommendations (2974)

Patient Problems Fall (1848); Pain (1994)

Event Date 01/20/2016

Event Type  malfunction  

Event Description

This mdr is being filed in an abundance of caution.The user reported that the tiller on his knee walker collapsed.He fell down injuring his toe but no medical treatment took place.Inspection of the subject knee walker showed that the unit had a tiller that had been installed backwards.

• Brand Name: FREE SPIRIT KNEE WALKER
• Type of Device: KNEE WALKER
• Manufacturer (Section D): LINKOU MEDICAL INDUSTRIAL CO. LTD.; no. 17 renhe road; nantou city, taiwan ; TW
• MDR Report Key: 5430661
• MDR Text Key: 38039176
• Report Number: 1056127-2016-00001
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00754756640002
• UDI-Public: 754756640002
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 02/11/2016,01/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: P4000
• Device Catalogue Number: P4000
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/11/2016
• Distributor Facility Aware Date: 01/21/2016
• Device Age: 4 YR
• Date Report to Manufacturer: 02/11/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/11/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 79