BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOLLOS

    MDR report key: 2909181 · Received November 26, 2012

    Report

    Report Number
    2909181
    Event Type
    Malfunction
    Date Received
    November 26, 2012
    Date of Event
    October 25, 2012
    Report Date
    November 26, 2012
    Manufacturer
    TOLLOS, INC. (FORMERLY T.H.E. MEDICAL)
    Product Code
    FNG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DE, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PATIENT WEIGHING 430 POUNDS WAS PLACED ON SLING FOR LIFTING. SLING BEING USED WAS APPROVED FOR 600 POUNDS. WHEN ATTEMPTING TO LIFT PATIENT UP IN THE BED, THE SLING TORE. NO HARM TO PATIENT. SLING WAS ONLY IN USE FOR TWO DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOLLOS LIFT, PATIENT, SLING FNG TOLLOS, INC. (FORMERLY T.H.E. MEDICAL) LARGE *

    Patients

    Seq Age Sex Outcome Treatment
    1 *