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

Model Number P4000

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

Patient Problems Bruise/Contusion (1754); Fall (1848)

Event Date 11/03/2014

Event Type  malfunction  

Event Description

Pt reports that he was using the knee walker on an asphalt parking lot when the tiller lock released and the tiller fell back toward him.He fell off the back of the knee walker and landed on the left side of his body, bruising his left arm, ribs and back.No medical attention was sought or needed.

• Brand Name: FREE SPIRIT KNEE WALKER
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): LIN KOU MEDICAL INDUSTRIAL CO.LTD; 17 renhe rd; nantou county; nantou city, r.o.c. ; TW
• Manufacturer (Section G): ESSENTIAL MEDICAL SUPPLY, INC.; 6420 hazeltine national dr.; orlando FL 32822
• Manufacturer Contact: 6420 hazeltine national dr.; orlando, FL 32822
• MDR Report Key: 4301568
• MDR Text Key: 19309256
• Report Number: 1056127-2014-00021
• Device Sequence Number: 1
• Product Code: ITJ
• 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: 11/05/2014

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: 11/25/2014
• Distributor Facility Aware Date: 11/05/2014
• Device Age: 3 MO
• Event Location: Other
• Date Report to Manufacturer: 11/25/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/28/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 104