MAUDE Adverse Event Report: UNKNOWN ROLL-A-BOUT SCOOTER; WALKER, MECHANICAL

Device Problem Mechanical Problem (1384)

Patient Problems Fall (1848); Memory Loss/Impairment (1958); Brain Injury (2219); Cognitive Changes (2551)

Event Type  Injury  

Event Description

The end-user was using the roll-a-bout scooter supplied to him by perkins medical supply and rose medical, to go to his vehicle when suddenly and without warning the roll-a-about scooter stopped and as a result, flung him forward causing him to land face first onto his cement driveway.He described contact of his face to the cement driveway as sounding like rice krispies.On this date he had a nurse at his home for the injury he sustained while working construction.Thus, after the failure of perkins medical supply and/or roscoe medical to provide instructions and warnings regarding use of the roll-a-bout scooter caused him to hit his head, the home nurse cleaned up the wound on his face.On (b)(6) 2018, his wife tells his foot doctor that he has been having memory issues.On (b)(6) 2018, worker's compensation finally sends him to a doctor to refer him to a neurologist for his memory loss.On (b)(6) 2019, worker's compensation finally gets him in to see a psychologist and he diagnoses him with a mild neurocognitive disorder secondary to a traumatic brain injury.On (b)(6) 2019, he reports his "memory is wrong" and that he does not "look forward to doing things or even seeing my family because i can't carry on a conversation".The doctor notes that "due to cognitive issues, patient is not able to work." he is now seeing a different doctor for treatment of his neurocognitive issue that is secondary to his traumatic brain injury.Per medical report, customer has 1 to 3 beers a day.We did not inform the manufacturer of this event as it is unknown if it is our product or not, we are instead notifying you.Thank you.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: ROLL-A-BOUT SCOOTER
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17535955
• MDR Text Key: 321158921
• Report Number: MW5142847
• Device Sequence Number: 1
• Product Code: ITJ
• 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: 03/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1