BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOLLOS

    MDR report key: 17283498 · Received July 7, 2023

    Report

    Report Number
    3008406502-2023-00002
    Event Type
    Malfunction
    Date Received
    July 7, 2023
    Date of Event
    June 12, 2023
    Report Date
    July 6, 2023
    Manufacturer
    1073849 ONTARIO LTD., DBA TOLLOS, INC.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER DID NOT PROVIDE TOLLOS (MANUFACTURER) WITH DETAILS OF THE EVENT. TOLLOS DOES NOT KNOW THE PATIENT AGE OR ANY OTHER DEMOGRAPHIC INFORMATION ABOUT THE PATIENT. VALUES ENTERED IN REGARD TO THE PATIENT IN THIS REPORT WERE ONLY ENTERED TO ALLOW THE FORM TO BE SUBMITTED. FURTHER, TOLLOS DOES NOT KNOW IF THE PATIENT WAS INJURED, SO A CLINICAL CODE OF 4582 WAS ENTERED.

    Description of Event or Problem · 0

    THE CUSTOMER (HOSPITAL) ONLY REPORTED THAT THEY HAD AN EVENT IN WHICH A LIFTING STRAP BROKE. CUSTOMER INDICATED PATIENT INJURY, BUT TOLLOS (MANUFACTURER) DOES NOT HAVE ANY FURTHER DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1543095 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