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

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
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.
Additional Manufacturer Narrative
Drive devilbiss evaluated the device and the evaluation revealed signs of wear.The missing pin the customer claims is the detent button on the back right wheel.This fell out due to severe stress on the detent button which caused it to shear.The stress caused deformation in the accompanying slot on the frame of the rollator as well.This was done due to extreme external forces.The pin falling out was a result of the stresses that caused the collapse.

• Brand Name: HUGO
• 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: 19397699
• Report Number: 2438477-2024-00026
• Device Sequence Number: 6776382
• 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: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2024
• Report Date (Section F): 08/13/2024

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 700-979
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/10/2024
• Event Location: Home
• Date Report to Manufacturer: 05/24/2024
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 08/13/2024
• 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: Required Intervention
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Weight: 200 KG
• Date Report Sent to FDA: 08/13/2024