MAUDE Adverse Event Report: RALON MEDICAL EQUIPMENT CO., LTD.9 DRIVE; WALKER

Model Number RTL10555RD

Device Problem Device Damaged Prior to Use (2284)

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

Event Date 10/03/2018

Event Type  Injury  

Event Description

Drive devilbiss healthcare is the initial importer of the device which is a walker.End-user had complained that the unit was broken.Drive was in the process of replacing the unit with another model when the incident occured.End-user was sitting on the defective unit when he fell through the back rest.He hit his head on the rocking chair that was behind him.He went to the hospital and was reportedly diagnosed with a brain bleed.He spent time in the surgical icu.

• Brand Name: DRIVE
• Type of Device: WALKER
• Manufacturer (Section D): RALON MEDICAL EQUIPMENT CO., LTD.9; xilian development zone; jinsha, danzao town; foshan, guangdong 52822 2; CH 528222
• MDR Report Key: 8002843
• MDR Text Key: 124954491
• Report Number: 2438477-2018-00055
• 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: Other
• Type of Report: Initial
• Report Date: 10/24/2018

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?: Yes
• Device Operator: No Information
• Device Model Number: RTL10555RD
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/24/2018
• Distributor Facility Aware Date: 10/05/2018
• Event Location: Home
• Date Report to Manufacturer: 10/26/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/24/2018
• 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: 86 YR
• Patient Weight: 81