BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICELOCK 621 RATCHET

    MDR report key: 18048303 · Received November 1, 2023

    Report

    Report Number
    3003764610-2023-00017
    Event Type
    Malfunction
    Date Received
    November 1, 2023
    Date of Event
    September 7, 2023
    Report Date
    December 1, 2023
    Manufacturer
    OSSUR HF
    Product Code
    ISH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LOCK FAILED TO PROVIDE SECURE SUSPENSION RESULTING IN THE USER FALLING AND SUSTAINING MINOR INJURIES. PRODUCT HAD BEEN IN THE FIELD FOR 51 MONTH BUT PRODUCT USAGE TIME IS UNKNOWN. LIKELY THE LOCKING PLATE AND ATTACHMENT PIN WERE WORN SO ATTACHMENT PIN WOULD RELEASE WITHOUT PRESSING THE RELEASE MECHANISM. PRODUCT WEAR IS A KNOWN DISADVANTAGE AS SLOW WEAR IN THE LOCKING PLATE CAN LEAD TO THE LOCK NOT PROVIDING SUPPORT IF EITHER FAILS.

    Description of Event or Problem · 0

    WHILE WALKING THE PIN CAME OUT OF THE LOCK AND THE PROSTHETIC LIMB FELL OFF. THE PATIENT FELL BACKWARDS TO THE FLOOR.

    Description of Event or Problem · 0

    WHILE WALKING THE PIN CAME OUT OF THE LOCK AND THE PROSTHETIC LIMB FELL OFF. THE PATIENT FELL BACKWARDS TO THE FLOOR BUT WAS NOT INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2025598 ICELOCK 621 RATCHET PROSTHETIC LOCK ISH OSSUR HF L-621000 HF190515

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown