MAUDE Adverse Event Report: LIN KOU MEDICAL INDUSTRIAL CO. LTD. FREE SPIRIT KNEE WALKER; WALKER, MECHANICAL

Model Number P4000

Device Problem Detachment Of Device Component (1104)

Patient Problem Soreness (2079)

Event Date 02/22/2014

Event Type  malfunction  

Event Description

End user was in process of making a turn when knee rest post "let loose" and turned.She lost balance temporarily but did not fall.She inspected walker and found broken weld.She experienced some soreness in her groin after the event but no injury.No medical treatment was required.

• Brand Name: FREE SPIRIT KNEE WALKER
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): LIN KOU MEDICAL INDUSTRIAL CO. LTD.; no. 17, renhe rd; nantou city, nantou county, r.o.c. ; TW
• MDR Report Key: 3736439
• MDR Text Key: 4223686
• Report Number: 1056127-2014-00006
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Unknown
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/03/2014,03/10/2014

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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/03/2014
• Distributor Facility Aware Date: 03/10/2014
• Device Age: 3 YR
• Event Location: Home
• Date Report to Manufacturer: 04/01/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/05/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 136