MAUDE Adverse Event Report: MEDICAL GROUP CARE, LLC KNEE SCOOTER; WALKER, MECHANICAL

Patient Problems Fall (1848); Pain (1994)

Event Date 09/29/2023

Event Type  Injury  

Event Description

The welds holding the scooter knee rest to the mounting stem broke, my knee slid off and my foot that recently had surgery hit the floor causing much pain.It is a walgreens knee scooter that gives mobility to people that have no or minimal use of an ankle or foot.It has four wheels, is steerable and has brakes.

• Brand Name: KNEE SCOOTER
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): MEDICAL GROUP CARE, LLC; 1035 collier center way suite 5; naples FL 34108
• MDR Report Key: 17949598
• MDR Text Key: 326004082
• Report Number: MW5147034
• 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: 10/13/2023

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: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/16/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White