BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOLLOS

    MDR report key: 14355210 · Received May 11, 2022

    Report

    Report Number
    3008406502-2022-00003
    Event Type
    Malfunction
    Date Received
    May 11, 2022
    Date of Event
    April 26, 2022
    Report Date
    May 10, 2022
    Manufacturer
    TOLLOS, INC.
    Product Code
    FSA
    UDI-DI
    00817956021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FACILITY HAS NOT SHAREED DETAILS WITH THE MANUFACTURER. THE FDA SENT THE MANUFACTIRER THE USER MEDWATCH 3500 REPORT AND MANY OF THE DETAILS IN THIS REPORT CAME FROM THAT. ON MAY 10, 2022, THE FACILITY CONTACTED THE MANUFACTURER AND ASKED THE MANUFACTURER TO COME ON-STE TO EVALUATE THE DEVICE AND INVESTIGATE POSSIBLE CAUSES. INITIAL ON-SITE EVALUATION IS SCHEDULED FOR MAY 12, 2022.

    Description of Event or Problem · 0

    DESCRIPTION COMES FROM THE FACILITY MEDWATCH FORM 3500 (FACILITY DID NOT PROVIDE THE MANUFACTURER WITH ANY EVENT INFORMAITON): FOUR STAFF MEMBERS WERE AT BEDSIDE TO HELP TRANSFER THE PATIENT FROM THE BEDSIDE CHAIR TO THE BED. THE PATIENT WAS IN A GRAY COMBI SLING THAT WAS ATTACHED TO THE LIFT. THE PATIENT WAS LIFTED STRAIGHT OUT OF THE CHAIR WITH THE NURSE AND CNA PROVIDING LEG SUPPORT AND THE CHARGE RN AND OCCUPATIONAL THERAPIST GUIDING THE PATIENT OVER THE BED. ONCE THE PATIENT WAS OVER THE EDGE OF THE BED, THE LIFT STRAP BROKE AND THE LIFT SPREADER BAR LANDED ON THE PATIENT'S CHEST, HITTING THE PATIENT IN THE FACE AND RIGHT SHOULDER. NOTE FROM MANUFACTURER: THE FACILITY DID NOT PROVIDE ANY DETAIL, INCLUDING PATIENT DETAIL, SO THE AGE AND BIRTHDATE LISTED IS JUST A PLACEHOLDER TO ALLOW SUBMISSION AND IS NOT THE ACTUAL AGE AND BIRTHDATE OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1998167 TOLLOS PATIENT LIFT FSA TOLLOS, INC. CIRRUS 750 00817956021

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Unknown Other