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

Model Number P4000

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Injury (2348); Joint Dislocation (2374)

Event Date 06/19/2020

Event Type  Injury  

Event Description

Patient was using a knee walker when the walker slid outward.Patient fell injuring shoulder and soft tissue of lower back.

• 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: 10457033
• MDR Text Key: 204525559
• Report Number: 1056127-2020-00006
• 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: 08/26/2020,07/31/2020

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: P4000
• Device Catalogue Number: P4000
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/26/2020
• Distributor Facility Aware Date: 07/31/2020
• Device Age: 2 MO
• Event Location: Home
• Date Report to Manufacturer: 08/25/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Weight: 100