BEUDAMED
    FDA Adverse Event Other Summary report: N

    FERNO 35-P PROFLEXX

    MDR report key: 2536335 · Received April 10, 2012

    Report

    Report Number
    1523574-2012-00008
    Event Type
    Other
    Date Received
    April 10, 2012
    Date of Event
    February 17, 2012
    Report Date
    April 10, 2012
    Manufacturer
    FERNO-WASHINGTON, INC.
    Product Code
    FPO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OPERATORS DID NOT MAINTAIN FIRM CONTROL OF THE STRETCHER WHILE TRANSPORTING PT IN AN ELEVATED POSITION OVER A BROKEN SECTION OF PAVEMENT. THERE WAS NO MALFUNCTION. DESPITE NO MALFUNCTION OCCURRING, MANUFACTURER IS REPORTING THIS INCIDENT AS IT IS UNABLE TO CLEARLY DELINEATE WHETHER OR NOT THE ABRASION / LACERATION MET THE DEFINITION OF A SERIOUS INJURY.

    Description of Event or Problem · 1

    WHILE WHEELING THE COT TO THE REAR OF THE AMBULANCE, THE WHEEL CAUGHT ON A BROKEN SECTION OF PAVEMENT AND TIPPED OVER. THE PT IMPACTED THE GROUND SUSTAINING AN ABRASION OR LACERATION. ACCORDING TO THE CUSTOMER, THE ABRASION / LACERATION WAS CLEANSED AND A BANDAGE WAS APPLIED. DESCRIBED AS "NOT SEVERE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FERNO 35-P PROFLEXX FRENO 35-P FPO FERNO-WASHINGTON, INC. 0015621

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other