MAUDE Adverse Event Report: ZHONGSHAN A&J MEDICAL EQUIPMENT CO., LTD. DRIVE; WALKER

Model Number	795BU
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Contusion (1787)
Date of Event	07/22/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(4) is the initial importer of the device which is a walker.(b)(4) has not received the unit back for evaluation.Weight cap on the device is 300 pounds.End-user's reported weight is (b)(6).End user was sitting in the device while being pushed out of doors.The device hit a bump in the pavement and the user fell out of the unit.She was taken by ambulance to the medical center where x-rays were performed.She was informed that she had trauma in her leg.She stayed overnight.The next day she had trouble walking and went to another hospital where she was admitted by 4 day with a diagnosis of hematoma on her leg muscles.Treatment was to allow the trauma to dissipate on its own.After hospital release, end-user fell again without the use of the device.

• Brand Name: DRIVE
• Common Device Name: WALKER
• Manufacturer (Section D): ZHONGSHAN A&J MEDICAL EQUIPMENT CO., LTD.; 3 shenghui south road; nantou town,; zhongshan city, ; CH
• MDR Report Key: 8933087
• Report Number: 2438477-2019-00057
• Device Sequence Number: 2048521
• Product Code: ITJ
• UDI-Device Identifier: 00822383221649
• UDI-Public: 822383221649
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 08/26/2019
• Report Date (Section F): 08/26/2019

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: 795BU
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/21/2019
• Device Age: 1 YR
• Event Location: Other
• Date Report to Manufacturer: 08/27/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/26/2019
• 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: Hospitalization
• Patient Age: 78 YR
• Patient Weight: 135
• Date Report Sent to FDA: 08/26/2019