BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVACARE FULL BODY, MESH SLING, XXL

    MDR report key: 9764976 · Received February 27, 2020

    Report

    Report Number
    1531186-2020-00007
    Event Type
    Injury
    Date Received
    February 27, 2020
    Report Date
    February 5, 2020
    Manufacturer
    NEW PROKIN INTERNATIONAL LTD
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    THE NURSING DIRECTOR ADVISED THAT THERE IS NO DEFICIENCY WITH THE SLING; IT IS INTACT, WITH NO TEARS. SHE INDICATED THAT THE SLING WAS TOO LARGE FOR THE PATIENT'S DEMOGRAPHICS, WHICH POTENTIALLY CONTRIBUTED TO THE EVENT. THE REPORTED WEIGHT OF THE PATIENT IS (B)(6) POUNDS. THE MAXIMUM WEIGHT CAPACITY OF THE R140 SLING IS 600 POUNDS. WHILE THERE IS NO MINIMUM WEIGHT REQUIREMENT, IT IS RECOMMENDED FOR PATIENTS WEIGHING AT LEAST 300 POUNDS. ULTIMATELY, THE PATIENT SLINGS OWNER¿S MANUAL STATES,¿ USE AN INVACARE APPROVED SLING THAT IS RECOMMENDED BY THE INDIVIDUAL¿S DOCTOR, NURSE OR MEDICAL ASSISTANT FOR THE COMFORT AND SAFETY OF THE INDIVIDUAL BEING LIFTED.¿ IT ALSO STATES, ¿INVACARE SLINGS ARE MADE SPECIFICALLY FOR USE WITH INVACARE LIFTS. FOR THE SAFETY OF THE PATIENT, DO NOT INTERMIX SLINGS AND LIFTS OF DIFFERENT MANUFACTURERS.¿ ONE OF THE LABELS ON THE SLING ITSELF ALSO WARNS, ¿USE ONLY ON INVACARE LIFT PRODUCTS.¿ THE NURSING DIRECTOR ADVISED THAT THE SLING'S TAG IS WORN FROM WASHING, AND THE DATE CODE IS NOT VISIBLE. THEREFORE, THE AGE OF THE DEVICE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    A NURSING DIRECTOR AT A FACILITY REPORTED THAT AN INCIDENT OCCURRED WHILE A PATIENT WAS BEING TRANSFERRED USING A NON-INVACARE LIFT WITH AN INVACARE R140 SLING. SHE STATED THAT THE PATIENT WAS BEING TRANSFERRED FROM ONE SURFACE TO ANOTHER SURFACE THAT WAS ABOUT 2-4 INCHES HIGHER, AND WHEN THE LIFT WAS AT THE HIGHER POSITION, THE PATIENT SLID OUT OF THE SLING BEFORE THE LOWER PART OF THEIR BODY REACHED THE SURFACE THEY WERE BEING TRANSFERRED TO. THE PATIENT ALLEGEDLY SUSTAINED A SUBDURAL HEMATOMA AND FRACTURED HAND FROM THE FALL. THE PATIENT WENT TO THE ER, AND X-RAYS WERE TAKEN WHICH IDENTIFIED THE FRACTURE. THE PATIENT'S HAND WAS WRAPPED UP, AND THEY WERE GIVEN PAIN MEDICINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227457 INVACARE FULL BODY, MESH SLING, XXL LIFT, PATIENT, NON-AC-POWERED FSA NEW PROKIN INTERNATIONAL LTD R140 NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other