BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYSTAND EVOLV GLIDER LARGE

    MDR report key: 16941036 · Received May 16, 2023

    Report

    Report Number
    2183634-2023-00001
    Event Type
    Injury
    Date Received
    May 16, 2023
    Date of Event
    March 27, 2023
    Report Date
    April 17, 2023
    Manufacturer
    ALTIMATE MEDICAL, INC.
    Product Code
    INO
    PMA / PMN Number
    K062402
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    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."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    916400 EASYSTAND EVOLV GLIDER LARGE STANDING FRAME INO ALTIMATE MEDICAL, INC. EVOLV GLIDER LARGE

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other