MAUDE Adverse Event Report: MILLENNIAL MEDICAL LIFE CRUTCHES

Device Problem Break (1069)

Patient Problem Fall (1848)

Event Date 11/08/2020

Event Type  Injury  

Event Description

Reporter stated that he is an amputee and he has been using a crutch for five months.On (b)(6) 2020 he was walking using the crutch and it snapped into two, and he fell to the ground.He called the manufacturer of the device and he was told the device should not be used for more than four weeks.The reporter stated his main complaint is that the device is a safety hazard for people especially for an amputee.

• Brand Name: LIFE CRUTCHES
• Type of Device: CRUTCH
• Manufacturer (Section D): MILLENNIAL MEDICAL; 308 w tubernacle st. ste 200; st. george's UT 84770
• MDR Report Key: 10884938
• MDR Text Key: 217975381
• Report Number: MW5098031
• Device Sequence Number: 1
• Product Code: IPR
• 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: 11/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Weight: 111