BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLORENCE BED/ ELECTRIC MED SURG BED

    MDR report key: 5145097 · Received September 25, 2015

    Report

    Report Number
    3009591865-2015-00002
    Event Type
    Injury
    Date Received
    September 25, 2015
    Date of Event
    August 25, 2015
    Report Date
    September 25, 2015
    Manufacturer
    UMANO MEDICAL INC
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    UMANO MEDICAL INC FILLING AS THE MANUFACTURER (B)(4) FILLING AS THE IMPORTER/LEGAL MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BED SLIDES ON THE FLOOR WHEN THE BRAKE POSITION IS ENGAGED. IT WAS REPORTED THAT A HOSPITAL EMPLOYEE/ USER WAS INJURED AS A RESULT OF THE ISSUE. IT WAS FURTHER REPORTED THAT A NURSE INJURED HIS BACK DURING PATIENT TRANSFER, BUT NO DETAILS REGARDING THE SEVERITY OF THE ALLEGED INJURY WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637289 FLORENCE BED/ ELECTRIC MED SURG BED HOSPITAL BED A-C POWERED ADJUSTABLE FNL UMANO MEDICAL INC FL23SE

    Patients

    Seq Age Sex Outcome Treatment
    1