BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOLLOS

    MDR report key: 17302477 · Received July 11, 2023

    Report

    Report Number
    3008406502-2023-00003
    Event Type
    Malfunction
    Date Received
    July 11, 2023
    Date of Event
    June 13, 2023
    Report Date
    June 13, 2023
    Manufacturer
    1073849 ONTARIO LTD., DBA TOLLOS, INC.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE FACILITY INDICATED THAT A LIFT FELL FROM THE CEILING RAIL THROUGH A CLOSED LIFT GATE. THE FACILITY INDICATED THAT A PATIENT WAS INJURED, BUT DID NOT PROVIDE ANY ADDITIONAL INFORMATION. THE FACILITY DID NOT NOTIFY THE MANUFACTURER (TOLLOS) AT THE TIME OF THE ALLEGED EVENT, BUT VERBALLY NOTIFIED THE MANUFACTURER ON (B)(6) 2023. NO WRITTEN NOTIFICATION OR OTHER INFORMATION SUCH AS EVENT DETAILS WERE PROVIDED BY THE FACILITY. IT SHOULD BE NOTED THAT THE PATIENT INFORMATION INDICATED ON THIS FORM (PATIENT IDENTIFIER AND AGE) ARE NOT ACCURATE BECAUSE THE FACILITY DID NOT PROVIDE THESE DETAILS. THE MANUFACTURER ENTERED THESE VALUES SOLELY TO ALLOW THE MEDWATCH FORM TO BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2148778 TOLLOS PATIENT LIFT (CEILING LIFT) FSA 1073849 ONTARIO LTD., DBA TOLLOS, INC. CIRRUS

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Prefer Not To Disclose