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

Model Number	10266HD-BK
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	10/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Per drive devilbiss healthcare mdr #2438477-2024-00004: drive devilbiss healthcare was notified of an incident involving a rollator by the end user, who stated that the rear wheel fell off, causing her to fall and hit her shoulder and head on the kitchen table.Paramedics responded to the scene but the end user refused to go to the hospital.The end user was eventually diagnosed by her physician with a torn deltoid muscle in her left arm and an injury to her quadricep muscle, and is receiving physical therapy.Drive devilbiss is currently investigating the incident, including attempting to retrieve the device for evaluation.An update will be filed if additional information becomes available.

• Brand Name: DRIVE DEVILBISS HEALTHCARE
• 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 ; 7209625412
• MDR Report Key: 18578698
• Report Number: 3014273557-2024-00001
• Device Sequence Number: 7780079
• Product Code: ITJ
• UDI-Device Identifier: 00822383931654
• UDI-Public: 822383931654
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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): 01/25/2024

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: 10266HD-BK
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2024
• Initial Report FDA Received Date: 01/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Female