MAUDE Adverse Event Report: NINGBO SHENYU MEDICAL EQUIPMENT CO., LTD. DRIVE; ROLLATOR

Model Number	R726RD
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Codes	Fall (1848); Damage to Ligament(s) (1952)
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a rollator by an end user, who stated "she was walking to her mail, and the front wheel got stuck in between the grass and the cement walkway, causing her to fall." she had to use her life alert button and the paramedics came.She injured her shoulder, elbow, and hip, had xrays taken at the er in (b)(6) hospital dignity health.Drive requested the unit be returned for investigation and will file an update if additional information becomes available.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• Manufacturer (Section D): NINGBO SHENYU MEDICAL EQUIPMENT CO., LTD.; west of tanjialing road; yuyao, zhejiang 31540 8; CH 315408
• MDR Report Key: 17330368
• Report Number: 2438477-2023-00094
• Device Sequence Number: 20315547
• Product Code: ITJ
• UDI-Device Identifier: 00822383233222
• UDI-Public: 822383233222
• 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): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/14/2023
• Report Date (Section F): 07/14/2023

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: R726RD
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/14/2023
• Date Report to Manufacturer: 07/21/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/14/2023
• 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: 53 KG
• Date Report Sent to FDA: 07/14/2023