MAUDE Adverse Event Report: ALTIMATE MEDICAL, INC. EASYSTAND EVOLV GLIDER LARGE; STANDING FRAME

Model Number EVOLV GLIDER LARGE

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Abrasion (1689); Cellulitis (1768)

Event Date 03/27/2023

Event Type  Injury  

Manufacturer Narrative

This is the first recorded scratch to a client on the knee assembly recorded for the easystand glider large model since its release in 2005.There have been more than 5500 large gliders distributed since its release.The device was delivered to the client on (b)(6)2023.The client transfers independently into the device and uses the device on alternate days.The client generally wears trousers when using the device.The client has an sci and was unaware of the initial graze due to sensory loss.The client sought medical attention 3-4 days after the graze appeared on his leg.The client had not performed any type of first aid treatment themselves when the scratch occurred as he was unaware of the injury.He was prescribed antibiotics (fluoxixillin 500mg) for a 5-day course.Further prescription for an additional 2 days was given as symptoms remained.The distributor provided photographs of the edge of the knee assembly bracket which the client claims he scratched his knee on.There did not appear to be anything unusual about the bracket in comparing it to brackets in inventory based upon the pictures.The knee assemblies were requested to be returned by the distributor for investigation.The distributor was supplied with replacement knee assemblies for the client's device.

Event Description

On april 17, 2023 altimate medical, inc.Received a notice from the distributor in the united kingdome there was an issue reported to them.The issue was "the client that uses the glider for his rehab has transferred into it and injured his knee, he scratched the skin of the top and it subsequently became infected and he got cellulitis, he and his therapist are worried that this could happen again.".

• Brand Name: EASYSTAND EVOLV GLIDER LARGE
• Type of Device: STANDING FRAME
• Manufacturer (Section D): ALTIMATE MEDICAL, INC.; 262 west first street; morton MN 56270
• Manufacturer (Section G): ALTIMATE MEDICAL, INC.; 262 west first street; morton MN 56270
• Manufacturer Contact: amy curtis ; 262 west first street; morton, MN 56270 ; 5076976393
• MDR Report Key: 16941036
• MDR Text Key: 315321788
• Report Number: 2183634-2023-00001
• Device Sequence Number: 1
• Product Code: INO
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K062402
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: EVOLV GLIDER LARGE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/17/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/16/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male