BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOLLOS

    MDR report key: 10042603 · Received May 11, 2020

    Report

    Report Number
    10042603
    Event Type
    Malfunction
    Date Received
    May 11, 2020
    Date of Event
    April 6, 2020
    Report Date
    April 9, 2020
    Manufacturer
    TOLLOS, INC.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    HOYER SLING STRAP WAS A NEWER ONE WITH 5 LOOPS ON EACH SIDE. PLATER WAS PLACED ON THE HOYER DEVICE. PATIENT WAS LIFTED OFF THE BED WITHOUT INCIDENT. ONCE THE PATIENT WAS NEAR THEIR CHAIR, NURSE WAS GUIDING THE HOYER TO THE CORRECT POSITION WHEN THE LOWER RIGHT EXTREMITY STRAP SNAPPED. NURSE WAS ABLE TO CATCH THE STRAP BEFORE THE PATIENT FELL AND GUIDE THE PATIENT INTO THE CHAIR. THE PATIENT WAS NOT HARMED IN THE INCIDENT. UPON INSPECTION THE RED STRAP ON THE HOYER SLING STRAP HAD ALMOST SHEERED COMPLETELY IN HALF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507147 TOLLOS LIFT, PATIENT, NON-AC-POWERED FSA TOLLOS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 30660 DA