BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVE

    MDR report key: 10958401 · Received December 7, 2020

    Report

    Report Number
    2438477-2020-00061
    Event Type
    Injury
    Date Received
    December 7, 2020
    Date of Event
    October 26, 2020
    Report Date
    December 7, 2020
    Manufacturer
    UNKNOWN
    Product Code
    FNJ
    UDI-DI
    00822383143026
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    (B)(6) IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A BED. WE HAVE NOT RECEIVED THE DEVICE FOR EVALUATION. WE WILL FILE AN UPDATED REPORT WHEN WE EVALUATE THE DEVICE. THIS REPORT IS IN RESPONSE TO MEDWATCH FILING 101545-2020-16. END-USER WAS TRYING TO GET INTO BED. SHE GRABBED THE RIGHT SIDE RAIL ON THE BED. SHE REPORTED THAT THE RAIL BECAME SHAKY. SHE LOST HER BALANCE, FELL AND HIT HER HEAD. SHE COMPLAINED OF PAIN IN SACRAL AND COCCYX AREA. THE RAIL MAY HAVE DETACHED FROM THE BED; HOWEVER, THIS HAS NOT BEEN CONFIRMED. IT IS UNKNOWN WHETHER A PRODUCT DEFECT OR USER ERROR/LACK OF MAINTENANCE LED TO THE INCIDENT. X-RAYS CONFIRMED A FRACTURED PELVIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1424977 DRIVE BED RAIL FNJ UNKNOWN 15201BV 00822383143026

    Patients

    Seq Age Sex Outcome Treatment
    1