MAUDE Adverse Event Report: COMBO(ZHONGSHAN)MEDICAL EQUIPMENT DRIVE DEVILBISS HEALTHCARE; WALKER, MECHANICAL

Model Number	10257BL-1
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Damage to Ligament(s) (1952)
Date of Event	10/06/2024
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 who stated that the front right fork assembly broke off while in use.The end user fell and tore his acl and was hospitalized.Attempts to gather additional information have been unsuccessful.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: DRIVE DEVILBISS HEALTHCARE
• Common Device Name: WALKER, MECHANICAL
• Manufacturer (Section D): COMBO(ZHONGSHAN)MEDICAL EQUIPMENT; no.6 tongxing east road,; dongsheng town; zhongshan city, guangdong province ; CH
• MDR Report Key: 20624147
• Report Number: 2438477-2024-00056
• Device Sequence Number: 15672059
• Product Code: ITJ
• UDI-Device Identifier: 00822383290331
• UDI-Public: 00822383290331
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 11/06/2024
• Report Date (Section F): 11/06/2024

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: 10257BL-1
• Device Catalogue Number: 10257BL-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/19/2024
• Event Location: Home
• Date Report to Manufacturer: 11/07/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/06/2024
• 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: Hospitalization
• Patient Sex: Male
• Date Report Sent to FDA: 11/06/2024