MAUDE Adverse Event Report: CC HSING COMPANY LIMITED HUGO; WALKER

Model Number	700-979
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	05/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Per drive devilbiss healthcare mdr #2438477-2024-00026: drive devilbiss healthcare was notified of an incident involving a rollator by the end user's son, who reported that a pin in the front right leg broke during use causing the end user to fall to the ground and hit her head.She received a ct scan and x-rays that revealed a left broken shoulder.As part of its complaint review and evaluation process, drive devilbiss healthcare will also notify the manufacturer of the product about this complaint.

• Brand Name: HUGO
• Common Device Name: WALKER
• Manufacturer (Section D): CC HSING COMPANY LIMITED; no. 1, benting; bentsuo village; sikao township, jiayi county chiayi 62348 ; TW 62348
• Manufacturer (Section G): CC HSING COMPANY LIMITED; no. 1, benting; bentsuo village; sikao township, jiayi county chiayi 62348 ; TW 62348
• Manufacturer Contact: kevin walls ; 33 golden eagle lane; littleton, CO 80127 ; 7202545756
• MDR Report Key: 19400316
• Report Number: 3014273557-2024-00002
• Device Sequence Number: 8393575
• Product Code: ITJ
• UDI-Device Identifier: 00754021210046
• UDI-Public: 754021210046
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/27/2024

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 700-979
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2024
• Initial Report FDA Received Date: 05/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Weight: 91 KG