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

Model Number	10266HD-BK
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	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's family member, who reported that a "spring came unscrewed," and that when she went to sit on the unit, she fell to the ground[?]due to brake failure." end user reportedly fell and hit her head but did not seek medical attention.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): CC HSING COMPANY LIMITED; no.1, benting; bentsuo villge; sikao township, jiayi county chiayi 62348 ; TW 62348
• MDR Report Key: 15313509
• Report Number: 2438477-2022-00081
• Device Sequence Number: 12301833
• Product Code: ITJ
• UDI-Device Identifier: 00822383931654
• UDI-Public: 822383931654
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 08/29/2022
• Report Date (Section F): 08/29/2022

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: 10266HD-BK
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 09/02/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/29/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Female
• Date Report Sent to FDA: 08/29/2022