BEUDAMED
    FDA Adverse Event Other Summary report: N

    COMFORT EXTENSION

    MDR report key: 3542375 · Received December 23, 2013

    Report

    Report Number
    3009402404-2013-00065
    Event Type
    Other
    Date Received
    December 23, 2013
    Date of Event
    December 12, 2013
    Report Date
    December 20, 2013
    Manufacturer
    JOERNS HEALTHCARE
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    JOERNS SENDING THE REPORT TO THE MFR.

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE MFR BY THE FACILITY ((B)(6)), PER THE FACILITY THE RESIDENT WAS ATTEMPTING A SUPERVISED MOVE FROM THE BED TO THE WHEELCHAIR. THE RESIDENT ROCKED BACK AND FORTH ON THE SIDE OF THE BED SEVERAL TIMES TO GAIN MOMENTUM TO STAND WHILE HOLDING THE DELUXE HANDLE. THE DELUXE HANDLE WAS ATTACHED TO THE COMFEXT AND THE COMFEXT WAS ATTACHED TO THE BED. THE COMFEXT DETACHED FROM THE BED AND THE RESIDENT FELL FORWARD OFF THE BED. SHE LANDED ON HER KNEES ON THE FLOOR. THE FACILITY PERFORMED AN EVALUATION AND X-RAYS FOR INJURIES. THE RESIDENT HAS BRUISING ON HER KNEES AND PAIN. COMPLAINT # (B)(4) AND RA # (B)(4) HAS BEEN ENTERED INTO OUR SYSTEM TO RETRIEVE THE COMFEXT FOR EVALUATION. AS OF THIS WRITING, THE COMFEXT HAS NOT BEEN RETURNED TO JOERNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672594 COMFORT EXTENSION PATIENT BED EXTENSION FNL JOERNS HEALTHCARE COMFEXT

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR