MAUDE Adverse Event Report: RALON MEDICAL EQUIPMENT DRIVE; WALKER

Model Number RTL10555BL

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problems Fall (1848); Head Injury (1879)

Event Date 04/09/2018

Event Type  Injury  

Event Description

Drive devilbiss healthcare is the initial importer of the device which is a walker.End-user was sitting on the device.He leaned back on the backrest and it fell off.He subsequently fell backwards and hit his head.He sought medical attention at the hospital for a cat scan.They are monitoring him for a concussion.

• Brand Name: DRIVE
• Type of Device: WALKER
• Manufacturer (Section D): RALON MEDICAL EQUIPMENT; xilian development zone; jinsha, danzao town; foshan, guangdong, 52822 2; CH 528222
• MDR Report Key: 7456655
• MDR Text Key: 106383564
• Report Number: 2438477-2018-00020
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 04/24/2018

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: RTL10555BL
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/24/2018
• Distributor Facility Aware Date: 04/10/2018
• Device Age: 38 MO
• Event Location: Nursing Home
• Date Report to Manufacturer: 04/26/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 91 YR
• Patient Weight: 73