MAUDE Adverse Event Report: WUXI KANGQIANG INDUSTRIAL DRIVE; ROLLATOR

Model Number	RTL10261BL
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Fall (1848); Head Injury (1879)
Type of Reportable Event	Malfunction
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a rollator by an end user, who stated that he "fell over while sitting on the unit" and reportedly scraped his head, elbow and knee.The end user reports that he did not seek any medical attention and claims that the leg of his rollator has broken.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): WUXI KANGQIANG INDUSTRIAL; 145 yipu road; dapu industrial park; yixing,, jiangsu 21420 6; CH 214206
• MDR Report Key: 17451877
• Report Number: 2438477-2023-00111
• Device Sequence Number: 7260904
• Product Code: ITJ
• UDI-Device Identifier: 00822383262765
• UDI-Public: 00822383262765
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 08/03/2023
• Report Date (Section F): 08/03/2023

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: RTL10261BL
• Device Catalogue Number: RTL10261BL
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/05/2023
• Device Age: 5 YR
• Date Report to Manufacturer: 08/03/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/03/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Female
• Date Report Sent to FDA: 08/03/2023