MAUDE Adverse Event Report: ROSCOE MEDICAL / COMPASS HEALTH BRANDS ROSCOE KNEE SCOOTER WITH BASKET, BLACK

Model Number ROS-KSB

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/31/2017

Event Type  No Answer Provided  

Event Description

Ordered a knee scooter from (b)(6) on (b)(6) 2017 in preparation for use following my wife's ankle fusion surgery.The unit is manufactured by (b)(4) medical.Just prior to her surgery on (b)(6) 2017, the scooter was assembled.About a week following surgery, she tried out the scooter and found at certain times there was no braking action.Further investigation revealed that the rear axle would shift from side to side causing the brake housing to move away from the braking drum.When the axle would slide in the other direction, the brake housing would cover the braking drum, and brakes could applied.Emailed (b)(4) medical on (b)(6) 2017 to see if there was solution to the problem.After numerous exchanges of emails, they stopped corresponding without providing a solution.A physical therapist came to the house on (b)(6) 2017 to show my wife how to use the scooter, and other items.She tried out the scooter, and when she found that the brakes could not be applied, she told my wife she could show my wife how to use it and the unit was unsafe.I further contacted (b)(6) and have heard nothing.Document number: (b)(4).Report number: (b)(4).The unit is "designed to maximize mobility during your recovery from foot, ankle or leg surgery or injury." mfr website url: (b)(4), retailer: (b)(6).Purchase date: (b)(6) 2017.

• Brand Name: ROSCOE KNEE SCOOTER WITH BASKET, BLACK
• Type of Device: KNEE SCOOTER
• Manufacturer (Section D): ROSCOE MEDICAL / COMPASS HEALTH BRANDS
• MDR Report Key: 6875887
• MDR Text Key: 86755669
• Report Number: MW5072193
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 09/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: ROS-KSB
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 74 YR