BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICEROSS DERMO

    MDR report key: 19961239 · Received August 12, 2024

    Report

    Report Number
    3003764610-2024-00006
    Event Type
    Injury
    Date Received
    August 12, 2024
    Report Date
    August 12, 2024
    Manufacturer
    OSSUR HF
    Product Code
    ISS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT FAILED TO PROVIDE SECURE SUSPENSION WHEN LOCKING PIN DISCONNECTED FROM UMBRELLA, WHEN USER WAS WALKING. USER FELL AND SUSTAINED BRUISING AND NERVE PAIN. NO INDICATION OF MATERIAL OR MANUFACTURING FAILURE. ISSUE LIKELY TO BE DUE TO LACK OR ABSENCE OF ADHESIVE AT THE THREADS WHICH SHOULD HAVE BEEN APPLIED BY THE CPO. USE OF INCOMPATIBLE LOCKING PIN FROM ANOTHER MANUFACTURER MAY HAVE CONTRIBUTED TO FAILURE. THE LIKELIHOOD OF THIS TYPE OF FAILURE LEADING TO A HAZARDOUS EVENT RESULTING IN A SERIOUS INJURY IS CONSIDERED REMOTE. FURTHER ACTIONS ARE NOT CONSIDERED WARRANTED.

    Description of Event or Problem · 0

    THE PIN DISCONNECTED FROM THE LINER CAUSING THE USER TO FALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1780704 ICEROSS DERMO LINER ISS OSSUR HF I-431328

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other