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

Model Number	795BK
Medical Device Problem Codes	Device Tipped Over (2589); Device Unsafe to Use in Environment (2918)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Fall (1848); Laceration(s) (1946)
Date of Event	05/27/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare is the initial importer of the device which is a rollator.The device was not returned for evaluation since it was not a device issue.We are filing this report in an over-abundance of caution due to an mdr regression analysis.End-user was at indy 500 sitting on the rollator while being pushed around.Rollator hit a bump and occupant fell forward.He hit his head suffering a cut and a bruise.Emts checked him and he was cleared.No additional medical attention was required.The device was not returned as it was not damaged.End-user stated that he used the device as a transport chair on other occasions where it tipped forward and he suffered no injuries.Ifu precautions note that seat should not be used on incline or uneven ground.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• Manufacturer (Section D): ZHONGSHAN A&J MEDICAL EQUIPMENT; 3 shenghui south road; nantou town; zhongshan city, guangdng ; CH
• MDR Report Key: 10762013
• Report Number: 2438477-2018-00110
• Device Sequence Number: 11034393
• Product Code: ITJ
• UDI-Device Identifier: 00822383213491
• UDI-Public: 822383213491
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 10/30/2020
• Report Date (Section F): 10/30/2020

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: Other
• Device Model Number: 795BK
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/31/2018
• Device Age: 18 MO
• Event Location: Other
• Date Report to Manufacturer: 10/30/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/30/2020
• 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: 10/30/2020