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

Model Number	790
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	08/21/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare is the initial importer of the device which is a knee walker.Drive does not expect to receive the product for evaluation.End-user is 6"5" and has just undergone surgery for a ruptured achilles tendon.He has had two (2) serious falls using the device.He had hit rocks in the road or joints in the concrete and has gone over the handle bars with the momentum of movement.The second fall caused lacerations.His wife picked up the unit.Instructions for use caution against traversing cracks in the road and loose gravel.Maximum height of the handle bar is 3 feet.

• Brand Name: DRIVE
• Common Device Name: KNEE WALKER
• Manufacturer (Section D): HL CORP (SHENZHEN); the 3rd industrial park; bitou village, songgang town; baoan district, shenzhen guangdong ; CH
• MDR Report Key: 8922837
• Report Number: 2438477-2019-00056
• Device Sequence Number: 1904130
• Product Code: ITJ
• UDI-Device Identifier: 00822383183589
• UDI-Public: 822383183589
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/22/2019
• Report Date (Section F): 08/22/2019

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
• Operator of Device: Lay User/Patient
• Device Model Number: 790
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/21/2019
• Device Age: 10 MO
• Event Location: Other
• Date Report to Manufacturer: 08/23/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Weight: 125
• Date Report Sent to FDA: 08/22/2019