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

Model Number P4000

Device Problem Fracture (1260)

Patient Problems Bleeding (1738); Fall (1848)

Event Date 04/14/2014

Event Type  malfunction  

Event Description

User was carrying lunch to his daughter at school in the rain when the frame of his knee walker cracked and he fell to the ground.The incision from a recent amputation began to bleed but was cared for with first aid only.Pt doing well at time of interview on (b)(6) 2014.

• Brand Name: FREE SPRIT 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: 3833521
• MDR Text Key: 4396976
• Report Number: 1056127-2014-00010
• 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: 04/24/2014

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: 05/16/2014
• Distributor Facility Aware Date: 04/24/2014
• Device Age: 7 YR
• Event Location: Other
• Date Report to Manufacturer: 04/30/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/16/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Weight: 82