MAUDE Adverse Event Report: MEDLINE INC GUARDIAN

Model Number G05161

Device Problem Break (1069)

Patient Problems Fall (1848); Injury (2348)

Event Date 01/20/2016

Event Type  Injury  

Event Description

I was recently prescribed forearm crutches and the vendor issued the medline "guardian" brand forearm crutches.The weight limitations are supposed to be up to (b)(6) support and i weight about (b)(6).While using the crutches to go from my living room to my kitchen, the crutch on my left arm snapped (there is a plastic adjustment bar that slides into a metal crutch) resulting in me falling onto the crutch that fell behind me as it broke where my right hip and upper spine hit not only the crutch, but the floor as well when i fell.I then had to crawl into the next room and be taken by ambulance to the hospital.I have had to have assistance with all activities since and waiting for further testing from my primary care physician to determine extent of injuries.

• Brand Name: GUARDIAN
• Type of Device: GUARDIAN
• Manufacturer (Section D): MEDLINE INC
• MDR Report Key: 5398049
• MDR Text Key: 37086189
• Report Number: MW5059764
• 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: Patient
• Type of Report: Initial
• Report Date: 01/22/2016

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
• Device Model Number: G05161
• Device Lot Number: 40315050025
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/22/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NAPROXEN 500MGS
• Patient Outcome(s): Hospitalization; Other; Disability
• Patient Age: 36 YR
• Patient Weight: 68