MAUDE Adverse Event Report: DRIVE MEDICAL WHEELCHAIR, MECHANICAL

Model Number CRUISER III WHEELCHAIR

Device Problem Material Integrity Problem (2978)

Patient Problem Fall (1848)

Event Date 07/01/2018

Event Type  Injury  

Event Description

Facility stating the breaks do not lock.Patient tipped over.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: WHEELCHAIR, MECHANICAL
• Type of Device: WHEELCHAIR, MECHANICAL
• Manufacturer (Section D): DRIVE MEDICAL
• MDR Report Key: 17531456
• MDR Text Key: 321132353
• Report Number: MW5138371
• Device Sequence Number: 1
• Product Code: IOR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: CRUISER III WHEELCHAIR
• Patient Sequence Number: 1