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

Model Number	RTL10266BK-T
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Fall (1848); Head Injury (1879)
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare is the initial importer of the device which is a rollator.This complaint was pulled from a consumer review website and we are unable to obtain any contact information from the user.The device was not returned for evaluation.We will file a follow-up when additional information becomes available.The frame broke while the user was sitting on his front porch.He fell and hit his head.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• Manufacturer (Section D): ZHONGSHAN A&J MEDICAL EQUIPMENT CO; 3 shenghui s road; nantou town; zhongshan city, guangdong ; CH
• MDR Report Key: 13009617
• Report Number: 2438477-2021-00076
• Device Sequence Number: 4926130
• Product Code: ITJ
• UDI-Device Identifier: 00822383523934
• UDI-Public: 822383523934
• Combination Product (Y/N): N
• 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): 12/15/2021
• Report Date (Section F): 12/15/2021

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: RTL10266BK-T
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/02/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Male
• Date Report Sent to FDA: 12/15/2021