MAUDE Adverse Event Report: JIANGYIN HUASHI MEDICAL DRIVE DEVILBISS HEALTHCARE; WALKER, MECHANICAL

Model Number	795BU
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Fall (1848)
Date of Event	06/17/2024
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 the brakes did not hold causing the end user to fall.The end user has fallen multiple times.The end user stated she had multiple cortisone injections to her back and feet.The insturctions for use for the rollator states," regularly test the brakes.Always engage and disengage wheel locks on both sides simultaneously.You may need to adjust the brake systems from time to time as they will wear out with normal use." 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): JIANGYIN HUASHI MEDICAL; no.589 hualu road; huashi town; jiangyin city, jiangsu 21442 1; CH 214421
• MDR Report Key: 19715878
• Report Number: 2438477-2024-00033
• Device Sequence Number: 15647876
• Product Code: ITJ
• UDI-Device Identifier: 00822383221649
• UDI-Public: 00822383221649
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 07/10/2024
• Report Date (Section F): 07/10/2024

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: 795BU
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/17/2024
• Event Location: Home
• Date Report to Manufacturer: 07/10/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/10/2024
• 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: 74 YR
• Patient Sex: Female
• Date Report Sent to FDA: 07/10/2024