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

Model Number	10289BL
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Laceration(s) (1946)
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's wife, who stated that "her husband was walking in the house and had a serious fall." there was no information provided regarding any defect, and the end user's wife stated that she was "unsure of what caused the fall." the end user cut his arm and injured his shoulder.Paramedics responded and transported the end user to the hospital, where he was admitted.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: 17321459
• Report Number: 2438477-2023-00092
• Device Sequence Number: 6903530
• Product Code: ITJ
• UDI-Device Identifier: 00822383259338
• UDI-Public: 822383259338
• 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): 07/13/2023
• Report Date (Section F): 07/13/2023

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: 10289BL
• Device Catalogue Number: 10289BL
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/13/2023
• Device Age: 8 MO
• Event Location: Home
• Date Report to Manufacturer: 07/20/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/13/2023
• 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: Male
• Date Report Sent to FDA: 07/13/2023