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

Model Number P4000

Device Problem Use of Device Problem (1670)

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

Event Date 11/14/2021

Event Type  malfunction  

Event Description

The end user noticed that the tiller on this knee walker seemed loose while using the device at a relative's home.She said she checked the handle bar and tiller assembly and used tools she carries with her to tighten the tiller mounting bolts.When she arrived home later that night, the tiller bent forward and separated from the device as she was transporting it in her driveway.No injury occurred.

• 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: 12960222
• MDR Text Key: 282562669
• Report Number: 1056127-2021-00004
• 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: 12/08/2021,11/16/2021

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
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/08/2021
• Distributor Facility Aware Date: 11/16/2021
• Device Age: 7 MO
• Event Location: Home
• Date Report to Manufacturer: 11/22/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 18 YR
• Patient Sex: Female
• Patient Weight: 141 KG
• Patient Ethnicity: Hispanic