MAUDE Adverse Event Report: DRIVE MEDICAL KNEE SCOOTER

Model Number 790

Device Problems Unstable (1667); Device Tipped Over (2589)

Patient Problems Fall (1848); Pain (1994)

Event Date 03/19/2018

Event Type  Injury  

Event Description

Patient called to report an adverse event and product issues with her drive knee scooter.Patient stated that she was using this scooter after having ankle surgery, and it was rented from a medical supply store.Patient stated that the front wheels are 18 inches apart, while the back wheels are 8 inches apart and that this creates instability when using the scooter.Patient said when mounting the scooter from the side, if the handle bars are tilted, you fall right over.Patient said she fell hard on her ankle that had surgery and it caused her such severe pain, she almost passed out.Patient said she feels the device may need to be recalled due to poor design and danger of tipping over.

• Brand Name: KNEE SCOOTER
• Type of Device: KNEE SCOOTER
• Manufacturer (Section D): DRIVE MEDICAL
• MDR Report Key: 7380857
• MDR Text Key: 103926419
• Report Number: MW5076202
• 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: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/28/2018

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: No Information
• Device Model Number: 790
• Device Catalogue Number: HX59JP
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/28/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 75 YR