BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOA MEDICAL SOFT TOUCH SIDE RAIL

    MDR report key: 1818793 · Received August 24, 2010

    Report

    Report Number
    1931947-2010-00001
    Event Type
    Injury
    Date Received
    August 24, 2010
    Date of Event
    August 2, 2010
    Report Date
    August 3, 2010
    Manufacturer
    NOA MEDICAL INDUSTRIES, INC.
    Product Code
    FNL
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS INSPECTED BY A TECHNICIAN FROM THE DISTRIBUTOR/RENTAL AGENCY, (B)(4). (B)(4) SENT A COPY OF THE SIDE RAIL SERVICE MANUAL TO ALL FACILITIES HIGHLIGHTING THE INSTRUCTIONS TO TIGHTEN THE ATTACHMENT PINS WITH A 1/2 OR ADJUSTABLE WRENCH. (B)(4) SENT TECHNICIANS TO ALL FACILITIES TO INSPECT ATTACHMENT PINS FOR PROPER INSTALLATION AND TO TIGHTEN ANY LOOSE PINS.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT ALLEGEDLY A SIDE RAIL ATTACHMENT PIN HAD BROKEN RESULTING IN THE RESIDENT FALLING AND FRACTURING HIS SHOULDER. A TECHNICIAN WAS SENT TO THE FACILITY AND FOUND THAT THE PIN HAD NOT BROKEN BUT IT WAS LOOSE. THE TECHNICIAN TIGHTENED THE PIN AND PUT THE RAIL BACK INTO SERVICE. THE ATTACHMENT PINS ARE ASSEMBLED ONTO THE SIDE RAILS BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOA MEDICAL SOFT TOUCH SIDE RAIL HOSPITAL BED SIDE RAIL FNL NOA MEDICAL INDUSTRIES, INC. 7540010BEI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization