MAUDE Adverse Event Report: CC HSING COMPANY LIMITED DRIVE; ROLLATOR

Model Number	RTL10266BK
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a rollator by an attorney, who stated "the end user suffered injuries to their right foot, requiring a toe amputation as a result of his use of the nitro euro style rollator." 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): CC HSING COMPANY LIMITED; no.1,benting; bentsuo villge; sikao township, jiayi county chiayi 62348 ; TW 62348
• MDR Report Key: 17330347
• Report Number: 2438477-2023-00093
• Device Sequence Number: 6302774
• Product Code: ITJ
• UDI-Device Identifier: 00822383523927
• UDI-Public: 822383523927
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: RTL10266BK
• Device Catalogue Number: RTL10266BK
• Was Device Available for Evaluation?: No
• 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: Male
• Date Report Sent to FDA: 07/14/2023