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

Model Number	RTL10266CH-H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Fall (1848); Head Injury (1879)
Date of Event	03/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare is the initial importer of the device which is a rollator.We have not received the device back for evaluation as it has been returned to the service provider.We will file a follow-up report when additional data is available.The brake cable of the device snapped while in use causing the end-user to fall and hit her head.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• Manufacturer (Section D): ZHONGSHAN A&J MEDICAL EQUIPMENT CO., LTD.; 3 shenghui south road; nantou town; zhongshan city, guangdong ; CH
• MDR Report Key: 12365760
• Report Number: 2438477-2021-00038
• Device Sequence Number: 4418214
• Product Code: ITJ
• UDI-Device Identifier: 00822383549484
• UDI-Public: 822383549484
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 08/18/2021
• Report Date (Section F): 08/23/2021

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: RTL10266CH-H
• Was the Report Sent to FDA?: Yes
• Device Age: 3 YR
• Event Location: Nursing Home
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/25/2021
• 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: Other
• Patient Age: 88 MO
• Patient Weight: 70
• Date Report Sent to FDA: 08/23/2021