MAUDE Adverse Event Report: HL CORP. (SHENZHEN) DRIVE; ROLLATOR

Model Number 10215RD-1

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Fall (1848); Injury (2348)

Event Date 10/03/2017

Event Type  Injury  

Event Description

(b)(4) is the initial importer of the medical device involved in this incident.It is a bariatric rollator with a weight cap of 500 pounds.The end-user was above the weight cap.The end-user went to sit down on the rollator.She said the brakes did not engage.The rollator slid out from under her and she fell.She was transported to the hospital where she was diagnosed with herniated discs.Her husband adjusted the brakes at the hospital and the rollator is working fine.The brakes were not engaged/set up properly.We are getting the unit back and replacing it with another.

• Brand Name: DRIVE
• Type of Device: ROLLATOR
• Manufacturer (Section D): HL CORP. (SHENZHEN); the 3rd industrial park; bitou village, song gang town; baoan district, shenzhen, guangdong 51810 5; CH 518105
• MDR Report Key: 7039335
• MDR Text Key: 92304057
• Report Number: 2438477-2017-00087
• 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: 11/16/2017,10/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 10215RD-1
• 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: 11/16/2017
• Distributor Facility Aware Date: 10/27/2017
• Device Age: 6 MO
• Event Location: Other
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Weight: 238