MAUDE Adverse Event Report: NINGBO SHENYU MEDICAL EQUIPMENT DRIVE; ROLLATOR

Model Number	R726RD
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Fall (1848); Head Injury (1879)
Date of Event	01/17/2022
Type of Reportable Event	No Answer Provided
Event or Problem Description
Drive devilbiss was notified of an adverse incident involving a rollator on (b)(6) 2022.The user reported "i was just sitting on my walker outside, and the wheel fell off and i fell cracking my head on the cement ground." her doctor's office was closed and there was no blood, but she had a "massive headache." when asked for photos of the device she advised that she did not know how to send photos from her phone and that she needed to wait until later.At the present we have not received awaiting the email with the photos.She was scheduled to see her doctor early (b)(6); however, we have been unable to acquire any additional data.Drive is currently investigating the incident, including attempting to retrieve the product and inspect it, and will file an update as soon as additional information becomes available.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• Manufacturer (Section D): NINGBO SHENYU MEDICAL EQUIPMENT; west of tanjialing road; yuyao, zhejiang, 31540 8; CH 315408
• MDR Report Key: 13655277
• Report Number: 2438477-2022-00006
• Device Sequence Number: 14897949
• Product Code: ITJ
• UDI-Device Identifier: 00822383233222
• UDI-Public: 822383233222
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 03/02/2022
• Report Date (Section F): 03/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: R726RD
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/17/2022
• Device Age: 16 MO
• Event Location: Home
• Date Report to Manufacturer: 03/03/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/02/2022
• 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: Other
• Patient Sex: Female
• Patient Weight: 71 KG
• Date Report Sent to FDA: 03/02/2022