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

Model Number P4000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Injury (2348)

Event Date 11/01/2017

Event Type  Injury  

Event Description

The knee walker allegedly failed and the patient fell, further injuring her foot and ankle.This rental unit was examined by the renting dealer and no defects or malfunction were found.

• 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 540 ; TW 540
• MDR Report Key: 8070014
• MDR Text Key: 127120969
• Report Number: 1056127-2018-00004
• 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: Other
• Type of Report: Initial
• Report Date: 11/14/2018,10/30/2018

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: P4000
• Device Catalogue Number: P4000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/14/2018
• Distributor Facility Aware Date: 10/31/2018
• Device Age: 2 YR
• Date Report to Manufacturer: 11/14/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 73