MAUDE Adverse Event Report: ZHENJIANG ASSURE MEDICAL EQUIPMENT, CO. LTS EQUATE; WALKER

Model Number	EQKW100
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026)
Health Effect - Clinical Codes	Abrasion (1689); Fall (1848)
Date of Event	09/17/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(6) is the initial importer of the device which is a walker.We have not received the unit for evaluation.When we evaluate the unit we will file a follow up report.The device moved unexpectedly while in use in the doctor's office causing the end-user to fall.The user reports bruising of her right leg which caused blood clots and arthritis.

• Brand Name: EQUATE
• Common Device Name: WALKER
• Manufacturer (Section D): ZHENJIANG ASSURE MEDICAL EQUIPMENT, CO. LTS; 297 chuqiao road; zhenjiang city, jiangsu 21200 0; CH 212000
• MDR Report Key: 10871384
• Report Number: 2438477-2020-00059
• Device Sequence Number: 16794558
• Product Code: ITJ
• UDI-Device Identifier: 00681131006880
• UDI-Public: 681131006880
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/19/2020
• Report Date (Section F): 11/19/2020

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: EQKW100
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/16/2020
• Device Age: 5 MO
• Event Location: Other
• Date Report to Manufacturer: 11/20/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 11/19/2020