BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUARDIAN

    MDR report key: 25302631 · Received May 27, 2026

    Report

    Report Number
    1417592-2026-01844
    Event Type
    Malfunction
    Date Received
    May 27, 2026
    Date of Event
    May 6, 2026
    Report Date
    May 27, 2026
    Manufacturer
    MEDLINE INDUSTRIES, LP
    Product Code
    IOR
    UDI-DI
    00193489099679
    PMA / PMN Number
    K990463
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE CUSTOMER, ON (B)(6) 2026 WHILE SEATED IN THE DEVICE AND ATTEMPTING TO PUT ON A "COMPRESSION SOCK," THE WHEEL "CAME OFF" AND THE INDIVIDUAL FELL TO THE FLOOR. THE CUSTOMER ALSO REPORTED THAT "PART OF THE WHEELCHAIR COLLAPSED ONTO" THE USER'S LEFT FOOT. PER THE CUSTOMER, THE INDIVIDUAL HAD LEFT FOOT SURGERY "10 WEEKS AGO." THE CUSTOMER DESCRIBED TWO SILVER NUTS "HAD DETACHED FROM THE CHAIR." THE CUSTOMER STATED THAT SHE "EXPERIENCED PAIN AND SWELLING ON THE TOP" OF THE "LEFT FOOT." THE CUSTOMER SOUGHT MEDICAL ATTENTION FROM THEIR ORTHOPEDIC SURGEON WHO DIAGNOSED A "SOFT TISSUE INJURY" AND WAS INSTRUCTED TO REMAIN "NON-WEIGHT BEARING" AND "ELEVATE AND ICE" THE INJURY. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IT HAS BEEN DETERMINED THAT THOUGH THE EVENT DID NOT INVOLVE A DEATH OR SERIOUS INJURY, RECURRENCE COULD CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY. BASED ON THE INFORMATION REVIEWED, THIS IS A REPORTABLE EVENT AS DEFINED UNDER 21 CFR 803.3.

    Description of Event or Problem · 0

    ACCORDING TO THE CUSTOMER, ON (B)(6) 2026 WHILE SEATED IN THE DEVICE AND ATTEMPTING TO PUT ON A "COMPRESSION SOCK," THE WHEEL "CAME OFF" AND THE INDIVIDUAL FELL TO THE FLOOR. THE CUSTOMER ALSO REPORTED THAT "PART OF THE WHEELCHAIR COLLAPSED ONTO" THE USER'S LEFT FOOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236848 GUARDIAN WC, K4, 16", SB DDLA, ELR IOR MEDLINE INDUSTRIES, LP 16425090001 00193489099679

    Patients

    Seq Age Sex Outcome Treatment
    1