MAUDE Adverse Event Report: DRIVE; ROLLATOR

Model Number 10233

Device Problem Fracture (1260)

Patient Problem Hip Fracture (2349)

Event Type  Injury  

Event Description

Drive devilbiss healthcare was notified of an incident involving a rollator.The end user's spouse reported that "the front leg collapsed yesterday.My husband is now in the hospital with a hip fracture and is awaiting hip surgery." the report was in the form of a comment on an e-commerce website, and drive is therefore unable to contact the end user directly to arrange for inspection of the unit or obtain further information regarding the incident.Drive will file an update to this report if additional information becomes available.

• Brand Name: DRIVE
• Type of Device: ROLLATOR
• MDR Report Key: 14948531
• MDR Text Key: 295447289
• Report Number: 2438477-2022-00040
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383118550
• UDI-Public: 822383118550
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/07/2022

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
• Device Operator: Lay User/Patient
• Device Model Number: 10233
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/07/2022
• Distributor Facility Aware Date: 02/22/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/07/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 109 KG