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

Model Number	RTL10266BK-T
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Fall (1848)
Date of Event	10/29/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident regarding a rollator on (b)(6) 2021.The end user have been using the device for all her mobility for approximately three years.The end-user reported that the "the front wheels is catching." she was using the device to go to the rest room and fell twice.She was attempting to go in one direction and reportedly fell since the device did not roll properly.There was an initial incident on (b)(6) when she was taken to the emergency room.She continued to use the device.She had a second incident (b)(6) and was admitted to the hospital.No additional information is available currently.The end user has not responded to our inquiries.The device has not been returned for evaluation.
Event or Problem Description
On (b)(6) 2021, drive devilbiss healthcare was notified of two separate accidents involving the same end user on the same rollator.The end user reported that one of the front wheels is "catching," and that she fell on two separate occasions when she attempted to go in one direction but the device did not roll properly.After the initial incident on (b)(6) 2021, she was treated in the emergency room.She continued to use the rollator and after the second incident, on (b)(6) 2021, she was admitted to the hospital.Drive has attempted to contact the end user to obtain additional information and retrieve the product for inspection.To date, the end user has not responded.Drive will update this report if additional information becomes available.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• Manufacturer (Section D): ZHONSHAN A&J MEDICAL EQUIPMENT CO; 3 shenghui s. road; nantou town; zhongshan city, guangdong ; CH
• MDR Report Key: 13656755
• Report Number: 2438477-2022-00013
• Device Sequence Number: 14776106
• Product Code: ITJ
• UDI-Device Identifier: 00822383523934
• UDI-Public: 822383523934
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 03/07/2022
• Report Date (Section F): 03/07/2022

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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/09/2021
• Device Age: 3 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 03/08/2022
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/02/2022
• Supplement Report FDA Received Date: 03/08/2022
• 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 Sex: Female
• Patient Weight: 85 KG
• Date Report Sent to FDA: 03/07/2022