BEUDAMED
    FDA Adverse Event Summary report: N

    TRANSFER CART

    MDR report key: 5032600 · Received August 26, 2015

    Report

    Report Number
    3005899764-2015-00057
    Date Received
    August 26, 2015
    Date of Event
    July 28, 2015
    Report Date
    August 26, 2015
    Manufacturer
    STERIS MEXICO, S. DE R.L. DE C.V.
    Product Code
    FLE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN INSPECTED THE TRANSFER CART AND FOUND TWO LOOSE NUTS ON THE RELEASE ROD HOWEVER, IT IS UNLIKELY THAT THIS WOULD HAVE RESULTED IN THE REPORTED EVENT TO OCCUR. THE TECHNICIAN STATED THAT THE REPORTED EVENT IS LIKELY ATTRIBUTED TO THE TRANSFER CART NOT BEING PROPERLY ALIGNED WITH THE TRACK THUS CAUSING THE REPORTED EVENT TO OCCUR. THE TECHNICIAN REPAIRED THE TRANSFER CART, TESTED IT FOR PROPER OPERATION AND ALIGNMENT TO THE STERILIZER AND RETURNED THE CART TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED. THE TECHNICIAN DISCUSSED THE PROPER USE AND OPERATION OF THE TRANSFER CART WITH USER FACILITY STAFF.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT WHILE AN EMPLOYEE WAS UTILIZING A TRANSFER CART TO LOAD THE STERILIZER SHE OBTAINED AN INJURY. THE EMPLOYEE SOUGHT AND RECEIVED MEDICAL TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565218 TRANSFER CART TRANSFER CART TO STERILIZER FLE STERIS MEXICO, S. DE R.L. DE C.V.

    Patients

    Seq Age Sex Outcome Treatment
    1