MAUDE Adverse Event Report: HL CORP DRIVE MEDICAL; WALKER

Model Number 790

Device Problem Unintended Movement (3026)

Patient Problem Rupture (2208)

Event Date 10/06/2015

Event Type  Injury  

Event Description

Drive medical received notice from an attorney regarding an incident involving a knee walker, a device imported and distributed by (b)(4).Enduser was using device in the public when device allegedly tipped over and enduser re-injured his leg.This report is based on information provided by the attorney for the enduser.

• Brand Name: DRIVE MEDICAL
• Type of Device: WALKER
• Manufacturer (Section D): HL CORP; the 3rd industrial park; bitou village song gang town; baoan district shenzhen, guangdong 51810 5; CH 518105
• MDR Report Key: 5237709
• MDR Text Key: 31659620
• Report Number: 2438477-2015-00031
• 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
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 11/18/2015,10/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 790
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/18/2015
• Distributor Facility Aware Date: 10/19/2015
• Device Age: 1 YR
• Event Location: Other
• Date Report to Manufacturer: 11/18/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/19/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR