MAUDE Adverse Event Report: DRIVE MEDICAL; WALKER, MECHANICAL

Model Number RTL10261BL

Device Problem Break (1069)

Patient Problem Contusion (1787)

Event Date 12/06/2016

Event Type  Injury  

Event Description

Drive is the initial importer of this device.End-user was in her living room using her walker.She stopped and turned to the left to open her blinds.The bar that is attached to the wheel snapped in half.End-user fell to the floor on her left side.She was taken by ambulance to the hospital with injuries to her side and back.X-ray and c-t scans showed contusion on the back.Pain medication was prescribed.

• Brand Name: DRIVE MEDICAL
• Type of Device: WALKER, MECHANICAL
• MDR Report Key: 6770269
• MDR Text Key: 81923509
• Report Number: 2438477-2017-00003
• 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: Patient
• Type of Report: Initial
• Report Date: 01/17/2017,12/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: RTL10261BL
• Device Catalogue Number: RTL10261BL
• Device Lot Number: N/A
• 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: 01/17/2017
• Distributor Facility Aware Date: 12/20/2016
• Event Location: Home
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/07/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention