BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-SERIES EASY SWIVEL CARRY BAR

    MDR report key: 10407547 · Received August 14, 2020

    Report

    Report Number
    3007802293-2020-00016
    Event Type
    Injury
    Date Received
    August 14, 2020
    Date of Event
    July 23, 2020
    Report Date
    October 6, 2020
    Manufacturer
    HANDICARE USA INC.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    HANDICARE HAS PROVIDED ADDITIONAL TRAINING FOR THE UNIT WHERE THE INCIDENT OCCURRED ON 9/9 AND 9/14. ALL STAFF WAS TRAINED.

    Additional Manufacturer Narrative · 1

    WE ARE FOLLOWING UP WITH THE CUSTOMER TO PROVIDE OUTSTANDING DETAILS OF THE INCIDENT. UPON RECEIPT, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE PATIENT WAS BEING TRANSFERRED IN A CEILING LIFT BY ONE CAREGIVER WHEN THE LOOP OF THE SLING SLIPPED FROM THE CARRY BAR. THE PATIENT FELL AND BROKE THEIR ANKLE. PER THE CAREGIVER, IT IS UNCLEAR IF THE SLING LOOP WAS PROPERLY ATTACHED TO THE CARRY BAR AT TIME OF THE INCIDENT. TRAINING HAD PREVIOUSLY BEEN DONE AT THE FACILITY. THE FACILITY INSPECTED THE EQUIPMENT AFTER THE INCIDENT TO VERIFY IT WAS FUNCTIONING CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    872461 C-SERIES EASY SWIVEL CARRY BAR CARRY BAR FSA HANDICARE USA INC. 360760

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization