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

Model Number UNKNOWN

Device Problems Break (1069); Detachment Of Device Component (1104); Sticking (1597)

Patient Problems Injury (2348); Fracture, Arm (2351)

Event Type  Injury  

Event Description

(b)(4) is the initial importer of the device which is a walker.The model number of the device as well as the date of the incident are unknown.The end-user was using the device while going downhill.She reported that the brakes caught, the brake handle broke off and she was thrown over the handle bars.She was taken to the er.Both of her arms were broken.The provider will not supply the user's name or personal information for this report citing hippa.

• Brand Name: DRIVE
• Type of Device: WALKER
• 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: 7501069
• MDR Text Key: 107821903
• Report Number: 2438477-2018-00021
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial
• Report Date: 05/09/2018

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: UNKNOWN
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/09/2018
• Distributor Facility Aware Date: 02/22/2018
• Device Age: 14 MO
• Event Location: Other
• Date Report to Manufacturer: 05/11/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention