MAUDE Adverse Event Report: HANGZHOU FUYANG HONGWEI METAL PRODUCT CO LTD DRIVE; ROLLATOR

Model Number	R800RD
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	Fall (1848); Head Injury (1879)
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 reported that while using the rollator, the right wheel fell off," causing her to fall and hit her head, and sustained "bruises on a lot of her body including head, neck, arms, armpit, down her side etc.," but that no bones were broken.The end user reported that "maintenance" at her assisted living facility told her that the threading for the rear axle is stripped.Drive is currently investigating the incident, including attempting to retrieve the product and inspect it, and will file an update if additional information becomes available.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• Manufacturer (Section D): HANGZHOU FUYANG HONGWEI METAL PRODUCT CO LTD; liaoan village, wanshi town; fuyang district; hangzhou city, zhejiang 31140 6; CH 311406
• MDR Report Key: 15374371
• Report Number: 2438477-2022-00080
• Device Sequence Number: 5661361
• Product Code: ITJ
• UDI-Device Identifier: 00822383524115
• UDI-Public: 00822383524115
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 09/07/2022
• Report Date (Section F): 09/07/2022

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: R800RD
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Nursing Home
• Date Report to Manufacturer: 09/12/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/07/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 52 KG
• Date Report Sent to FDA: 09/07/2022