MAUDE Adverse Event Report: CC HSING COMPANY LIMITED DRIVE DEVILBISS HEALTHCARE; WALKER, MECHANICAL

Model Number	RTL10266
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Laceration(s) (1946); Concussion (2192)
Date of Event	09/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devillbiss healthcare was notified of an incident involving a rollator that the curb assist broke and the end user fell, cut her head and required 12 stitches.The end user was admitted to the hospital for 2 days with a concussion and 2 pints blood loss.Devilbiss is currently investigating the incident, including attempting to retrieve the device for investigation.An update will be filed if additional information becomes available.

• Brand Name: DRIVE DEVILBISS HEALTHCARE
• Common Device Name: WALKER, MECHANICAL
• Manufacturer (Section D): CC HSING COMPANY LIMITED; no. 1 benting; bentsuo village, sikao chiayi 26989 61; TW 2698961
• MDR Report Key: 18095652
• Report Number: 2438477-2023-00140
• Device Sequence Number: 17809949
• Product Code: ITJ
• UDI-Device Identifier: 00822383288819
• UDI-Public: 822383288819
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/08/2023
• Report Date (Section F): 11/08/2023

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: RTL10266
• Device Catalogue Number: RTL10266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2023
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/13/2023
• Event Location: Home
• Date Report to Manufacturer: 11/08/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/08/2023
• 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: Female
• Date Report Sent to FDA: 11/08/2023