MAUDE Adverse Event Report: HEBEI HEALTHPLUS MEDICAL DEVICE CO LTD DRIVE; ROLLATOR

Model Number	R728BL
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Fall (1848)
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 walker the wheel bearings came out causing the wheel to fall off and she fell." the end user sought treatment at a hospital, where she reportedly had ct scans and mris, however, did not report the results of those studies.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): HEBEI HEALTHPLUS MEDICAL DEVICE CO LTD; no. 1, chuangye st,; sw industrial dist,; handan city, hebei 05604 6; CH 056046
• MDR Report Key: 15447516
• Report Number: 2438477-2022-00079
• Device Sequence Number: 14640170
• Product Code: ITJ
• UDI-Device Identifier: 00822383233246
• UDI-Public: 00822383233246
• 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): 09/19/2022
• Report Date (Section F): 09/19/2022

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
• Device Model Number: R728BL
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/24/2022
• Device Age: 3 YR
• Event Location: Home
• Date Report to Manufacturer: 09/26/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/19/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Patient Sex: Female
• Date Report Sent to FDA: 09/19/2022