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

Model Number P4000

Device Problems Use of Device Problem (1670); Misassembly by Users (3133)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/25/2020

Event Type  malfunction  

Event Description

End user was using knee scooter in mall when the handle snapped off at the tiller locking assembly.No injury occurred.

• Brand Name: FREE SPIRIT KNEE WALKER
• Type of Device: WALKER
• Manufacturer (Section D): LINKOU MEDICAL INDUSTRIAL CO. LTD.; no. 17 renhe road; nantou city 540 ; TW 540
• MDR Report Key: 10685113
• MDR Text Key: 211643577
• Report Number: 1056127-2020-00009
• 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: 10/15/2020,09/28/2020

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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/15/2020
• Distributor Facility Aware Date: 09/28/2020
• Device Age: 6 YR
• Event Location: Other
• Date Report to Manufacturer: 10/13/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Weight: 76