MAUDE Adverse Event Report: DRIVE YOUTH CRUTCHES

Model Number 10431-8

Device Problems Deformation Due to Compressive Stress (2889); Device Operates Differently Than Expected (2913)

Patient Problems Fall (1848); Injury (2348)

Event Date 07/17/2015

Event Type  malfunction  

Event Description

(b)(6) year old patient with knee injury, given crutches for non-weight bearing right knee.One crutch buckled when the patient began to use the crutches, causing the patient to fall and hit her head.The plastic piece that locks the length of the crutch leg does not lock - defective - pulls off of crutch.Patient did not suffer additional injury.Patient given second set of crutches.Defective pair of crutches sequestered to be returned to manufacturer.Eight year old patient suffered right knee injury in a bicycle crash.

• Brand Name: DRIVE YOUTH CRUTCHES
• Type of Device: DRIVE YOUTH CRUTCHES
• MDR Report Key: 4949662
• MDR Text Key: 6633925
• Report Number: MW5044857
• Device Sequence Number: 1
• Product Code: INP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/23/2015

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 10431-8
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/23/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 8 YR
• Patient Weight: 28