MAUDE Adverse Event Report: JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT DRIVE; WHEELCHAIR

Model Number	K320DDA-SF
Medical Device Problem Codes	Unintended Movement (3026); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Fall (1848); Damage to Ligament(s) (1952)
Date of Event	01/19/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(6) is the initial importer of the device which is a wheelchair.We were unable to retrieve the unit for evaluation.We are filing this report in an over-abundance of caution due to an mdr regression analysis.End-user was transferring from his vehicle to the wheelchair when the brakes slipped.The end-user fell out of the chair and hit his truck.He tore a ligament in his knee.He had surgery to repair the damage.

• Brand Name: DRIVE
• Common Device Name: WHEELCHAIR
• Manufacturer (Section D): JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT; 36 danyang road; danyang, jiangsu 21230 0; CH 212300
• MDR Report Key: 10976552
• Report Number: 2438477-2018-00091
• Device Sequence Number: 4258519
• Product Code: IOR
• UDI-Device Identifier: 00822383123370
• UDI-Public: 822383123370
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/09/2020
• Report Date (Section F): 12/09/2020

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: K320DDA-SF
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/19/2019
• Device Age: 8 MO
• Event Location: Other
• Date Report to Manufacturer: 12/10/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/09/2020
• 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 Weight: 132
• Date Report Sent to FDA: 12/09/2020