BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEAD SECTION HALF LENGTH SIDE RAIL

    MDR report key: 2227422 · Received August 17, 2011

    Report

    Report Number
    1931947-2011-00003
    Event Type
    Injury
    Date Received
    August 17, 2011
    Date of Event
    July 27, 2011
    Report Date
    August 15, 2011
    Manufacturer
    NOA MEDICAL INDUSTRIES, INC
    Product Code
    FNJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MODEL SIDE RAIL, (B)(4), HAS BEEN IN PRODUCTION AND DISTRIBUTION SINCE 1996 WITHOUT ANY PREVIOUS HISTORY OF COMPLAINTS RELATING TO INJURIES FROM THE LATCH KNOB. WE DO NOT BELIEVE THE KNURL ON THE KNOB CONTRIBUTED TO THE LACERATION ON THE BACK OF THE RESIDENT'S LEG WHICH OCCURRED WHEN THE RESIDENT FELL DURING TRANSFER FROM WHEEL CHAIR INTO BED. AT THE SAME TIME, THE KNURL ON THE LATCH KNOB HAS NO PURPOSE OTHER THAN DECORATIVE. THE KNURL HAS BEEN REMOVED FROM THE DESIGN OF THE LATCH KNOB. THIS CUSTOMER FACILITY IS BEING SUPPLIED WITH NEW REPLACEMENT KNOBS THAT DO NOT HAVE THE KNURL. AT THIS TIME, WE VIEW THE CHANGE AS MORE RELATED TO CUSTOMER PERCEPTION AND SATISFACTION THAN CORRECTING A PRODUCT SAFETY ISSUE. WE WILL CONTINUE TO MONITOR EXISTING (B)(4) SIDE RAILS IN THE FIELD FOR ANY TYPE OF SIMILAR COMPLAINT.

    Description of Event or Problem · 1

    FEMALE RESIDENT WITH EXTREMELY THIN SKIN WAS BEING TRANSFERRED FROM HER WHEEL CHAIR INTO BED AND FELL. WHEN SHE FELL, THE BACK OF HER LEG RUBBED UP AGAINST SOMETHING WHICH CAUSED A LACERATION ON THE BACK OF HER LEG REQUIRING FORTY STITCHES. THE FACILITY STAFF DOES NOT KNOW FOR CERTAIN WHAT HER LEG RUBBED AGAINST BUT THE STAFF FEELS THE MOST LIKELY OBJECT IS A KNURLED LATCH KNOB THAT IS USED ON THE SIDE RAIL. THE FACILITY STAFF BELIEVES THE KNURL CONTRIBUTED TO THE LACERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEAD SECTION HALF LENGTH SIDE RAIL HOSPITAL BED SAFETY SIDE RAIL FNJ NOA MEDICAL INDUSTRIES, INC 75400002BLK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other