BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLAMINGO

    MDR report key: 11541990 · Received March 22, 2021

    Report

    Report Number
    3001657382-2021-00002
    Event Type
    Injury
    Date Received
    March 22, 2021
    Date of Event
    February 12, 2021
    Report Date
    March 22, 2021
    Manufacturer
    R82 A/S
    Product Code
    INM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT OCCURRED AS THE USER LEANT FORWARD AFTER THE HELPER HAD LOOSENED BOTH THE H-CHEST BELT AND THE HIP BELT. AS A CONSEQUENCE THE USER'S FULL WEIGHT WAS PUSHING OUT AGAINST THE SWING-AWAY ARM SUPPORT THAT IS DESIGNED FOR SUPPORTING THE ARMS IN A SEATED POSITION. THE BREAK OF THE HOLDER AROSE DUE TO THE EXCESSIVE BODY LOAD PUT ON THE ARM SUPPORT.STRENGTH OF BRACKET TESTED IN PRODUCT TEST (ACCORDING TO EN 12182). NO SIMILAR CASES SINCE LAUNCH IN 1999. BASED ON THE PATIENT'S DISABILITY, THE REHABILITATION PROCESS WILL BE MUCH MORE DIFFICULT COMPARED TO A CHILD OF THE SAME AGE WITHOUT DISABILITY. THE PATIENT IS AT A VERY LOW LEVEL. WILL BE DIFFICULT TO TRAIN AND DIFFICULT TO UNDERSTAND RECOMMENDATIONS AFTERWARDS, SUCH AS STEP MARKING / WHAT LOAD MAY BE PLACED ON THE LEG. ALREADY BEFORE THE CASE HAD DIFFICULTY SUPPORTING THE LEG, UNCLEAR WHY, HAVE WAITED FOR X-RAY TIME.

    Description of Event or Problem · 1

    THE PATIENT HAS FALLEN FROM HIS HYGIENE CHAIR WHICH WAS FIXED ON THE TOILET IN THE HOME AND IN THE CASE BROKE HIS LEG. THE CASE OCCURRED WHEN THE PARENT / ASSISTANT UNBUTTONED THE PATIENT'S H-HARNESS AND HIP BELT TO DRY AFTER A TOILET VISIT AND THE PATIENT THEN LEANED WITH A LARGE PART OF THE BODY WEIGHT OVER THE FOREARM SUPPORTS WHICH GAVE WAY AND CAME LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440733 FLAMINGO FLAMINGO INM R82 A/S 8805503

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization