BEUDAMED
    FDA Adverse Event Summary report: N

    OMNICYCLE ELITE

    MDR report key: 3879533 · Received June 10, 2014

    Report

    Report Number
    1911273-2014-00002
    Date Received
    June 10, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 23, 2014
    Manufacturer
    MEDICA MEDIZINTECHNIK GMBH
    Product Code
    BXB
    PMA / PMN Number
    EXCEPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NV, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2014 ACCELERATED CARE PLUS (DISTRIBUTOR) STAFF TOOK PICTURES OF THE OMNICYCLE AFTER THE EVENT. THE CYCLE'S LEFT AND RIGHT SIDE CALF SUPPORT AND VELCRO STRAPS WERE NOT ATTACHED, AND THE RIGHT SIDE CALF SUPPORT BAR WAS DETACHED FROM FOOT PEDAL. THE FIRST VIEWING OF X-RAY WAS REPORTED AS AN OLD FRACTURE ANTERIOR TIBIA, SECOND VIEWING OF X-RAY WAS REPORTED AS A NEW FRACTURE. THE PATIENT IS CONFIRMED AS HAVING EXISTING OSTEOPOROSIS.

    Description of Event or Problem · 1

    PATIENT WAS PEDALING USING LOWER EXTREMITY EXERCISER ON THE OMNICYCLE. PATIENT'S LEFT PANT LEG GOT CAUGHT IN CRANK ARM WHICH TWISTED PANTS AROUND PATIENT'S LEG. NO ONE HAD NOTICED THE PANTS BEING TWISTED AROUND PATIENT'S LEG UNTIL THE PATIENT CRIED OUT. THERAPIST THEN PUSHED THE STOP BUTTON TO STOP SESSION. PATIENT INCURRED BRUISING AND AFTER CONTINUED SWELLING, AND WAS SENT FOR X-RAY. THE FIRST VIEWING OF X-RAY WAS REPORTED AS AN OLD FRACTURE ANTERIOR TIBIA, SECOND VIEWING OF X-RAY WAS REPORTED AS A NEW FRACTURE. PATIENT HAS DIAGNOSIS HISTORY OF OSTEOPOROSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338331 OMNICYCLE ELITE EXERCISER, POWERED BXB MEDICA MEDIZINTECHNIK GMBH A000-533 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention