BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY

    MDR report key: 15970335 · Received December 13, 2022

    Report

    Report Number
    3005905321-2022-00001
    Event Type
    Injury
    Date Received
    December 13, 2022
    Date of Event
    October 27, 2022
    Report Date
    November 2, 2022
    Manufacturer
    KI MOBILITY, LLC
    Product Code
    IOR
    UDI-DI
    00850013379125
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INCIDENT OCCURRED ON (B)(6) 2022 THAT RESULTED IN A COMPRESSION OF THE DISTAL PHALANGES WHEN THE PATIENTS FINGER WAS TRAPPED BETWEEN THE BUMPER, SEAT FRAME AND THE SEAT FRAME OR BETWEEN THE BUMPER, SEAT FRAME MOUNT AND SEAT FRAME DURING TILT POSITIONING. DUE TO THE SEVERITY OF THE ALLEGED INCIDENT, THIS REPORT IS BEING FILED WHILE THE INVESTIGATION IS UNDERWAY.

    Additional Manufacturer Narrative · 0

    IT WAS DETERMINED BY THE INVESTIGATION OF THIS ADVERSE EVENT THAT ADDITIONAL PINCH POINT LABELING WAS NEEDED TO WARN USERS OF AN ORIGINALLY UNRECOGNIZED POTENTIAL HAZARD. AN ECO WAS INITIATED, TWO ADDITIONAL PINCH POINT LABELS WERE ADDED TO THE DEVICE, AND ADDITIONAL PINCH POINT WARNINGS WERE ADDED TO THE OWNER'S MANUAL FOR THE DEVICE.

    Description of Event or Problem · 0

    WHILE THE CHAIR WAS BEING TILTED, THE END USER'S FINGER WAS INJURED BY BEING PINCHED NEAR THE WHEEL LOCK. END USER'S HAND WAS IN THE AREA OF THE FRAME/WHEEL LOCK WHEN BEING TILTED. ALLEGED EVENT OCCURRED AT (B)(6) FACILITY DURING REHAB. AS PART OF THE INVESTIGATION, IT WAS DETERMINED THAT THE OWNER'S MANUAL INCLUDES WARNINGS OF THE PINCH POINTS IN QUESTION AND WAS PROVIDED TO THE END USERS' CAREGIVER AT DELIVERY OF THE WHEELCHAIR.

    Description of Event or Problem · 0

    WHILE THE CHAIR WAS BEING TILTED, THE END USER'S FINGER WAS INJURED BY BEING PINCHED NEAR THE WHEEL LOCK. END USER'S HAND WAS IN THE AREA OF THE FRAME/WHEEL LOCK WHEN BEING TILTED. ALLEGED EVENT OCCURRED AT (B)(6) FACILITY DURING REHAB. AS PART OF THE INVESTIGATION, IT WAS DETERMINED THAT THE OWNER'S MANUAL INCLUDES WARNINGS OF THE PINCH POINTS IN QUESTION AND WAS PROVIDED TO THE END USERS' CAREGIVER AT DELIVERY OF THE WHEELCHAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423760 LIBERTY MECHANICAL WHEELCHAIR IOR KI MOBILITY, LLC LIBERTY 00850013379125

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization| S