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

Model Number P4000

Device Problems Device Maintenance Issue (1379); Device Handling Problem (3265)

Patient Problems Fall (1848); Head Injury (1879); No Information (3190)

Event Date 01/12/2015

Event Type  malfunction  

Event Description

Patient reported to the homecare dealer in (b)(6) 2015 that he had fallen four times with the knee walker.He advised her to retain unit pending a legal action.On (b)(6) 2017 we were notified by mail of a legal claim filed and contacted the dealer.There are non-specific reports of injury and other than a loose tiller, the dealer did not find anything wrong with the unit.Additional reports will be filed as more information becomes available.

• 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 540 ; TW 540
• MDR Report Key: 6322052
• MDR Text Key: 67127537
• Report Number: 1056127-2017-00002
• 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: 02/10/2017,01/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2017
• 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?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/10/2017
• Distributor Facility Aware Date: 01/17/2015
• Device Age: 4 YR
• Date Report to Manufacturer: 02/10/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 77