BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECHRIST INDUSTRIES INC

    MDR report key: 20954667 · Received December 17, 2024

    Report

    Report Number
    2020676-2024-00024
    Event Type
    Injury
    Date Received
    December 17, 2024
    Date of Event
    December 5, 2024
    Report Date
    December 17, 2024
    Manufacturer
    SECHRIST INDUSTRIES INC.
    Product Code
    FPO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THIS STRETCHER IS NO LONGER MANUFACTURED OR SERVICED BY SECHRIST. THIS REPORTED IS BASED SOLEY ON THER INFORMATION PROVIDED BY THE CUSTOMER, ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED AT THIS TIME. THERE IS NO EVIDENCE THAT A MANUFACTURING NON-CONFORMITY CONTRIBUTED TO THE REPORTED COMPLAINT, AND THE INSTRUCTIONS FOR USE (IFU) WERE REVIEWED AND DETERMINED TO PROVIDE ADEQUATE INSTRUCTIONS AND WARNINGS FOR THE SAFE USE OF THE DEVICE. THEREFORE, NO CORRECTIVE OR PREVENTIVE ACTIONS ARE NECESSARY AT THIS TIME. ALL COMPLAINTS ARE TRENDED AND REVIEWED BY MANAGEMENT ON A MONTHLY BASIS. AS PART OF THIS MONTHLY REVIEW, ANY EXCURSION ABOVE THE CONTROL LIMITS FOR THIS FAILURE MODE WILL BE ASSESSED, DOCUMENTED, AND ACTED UPON AS WARRANTED. MANUFACTURER REFERENCE FILE NO.: (B)(4).

    Description of Event or Problem · 0

    AS REPORTED BY THE CUSTOMER, "AFTER I LOADED THE PATIENT INTO THE CHAMBER AND UNLOCKED THE STRETCHER, I ATTEMPTED TO ADJUST ITS POSITION. WHILE MOVING THE STRETCHER, MY HAND GRAZED OVER THE HINGE OF THE HANDLE, RESULTING IN A LACERATION TO THE RIGHT HAND PINKY FINGER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291662 SECHRIST INDUSTRIES INC STRETCHER, WHEELED FPO SECHRIST INDUSTRIES INC. P8000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other