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

Device Problem Mechanical Problem (1384)

Patient Problem Bone Fracture(s) (1870)

Event Date 11/06/2023

Event Type  Injury  

Event Description

Drive devilbiss healthcare was served with a legal complaint regarding a "4-wheel walker with seat," which presumably refers to a rollator.The complaint alleges that the rollator's brakes failed, causing the end user to fall, hit her head, and sustain a left thumb proximal phalanx fracture.Drive is currently attempting, through counsel, to identify the product, including model and serial number, and investigate the incident, including an inspection of the product.Drive will file an update as soon as additional information becomes available.

• Brand Name: DRIVE DEVILBISS HEALTHCARE
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): DRIVE DEVILBISS; 99 seaview blvd.; port washington NY 11050
• MDR Report Key: 18287174
• MDR Text Key: 329995849
• Report Number: 2438477-2023-00147
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/07/2023

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
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/07/2023
• Distributor Facility Aware Date: 11/06/2023
• Event Location: Home
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/07/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female