BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNKNOWN

    MDR report key: 2065560 · Received April 5, 2011

    Report

    Report Number
    1931947-2011-00002
    Event Type
    Other
    Date Received
    April 5, 2011
    Date of Event
    March 29, 2011
    Report Date
    April 1, 2011
    Manufacturer
    NOA MEDICAL INDUSTRIES, INC
    Product Code
    FNJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS FILED ON THE SIDE OF CAUTION DUE TO ALLEGATION OF A POSSIBLE TYPE OF ENTRAPMENT. OUR SIDE RAILS COMPLY WITH CURRENT ENTRAPMENT GUIDELINES. WE HAVE NEVER RECEIVED NOTICE OF AN INCIDENT LIKE THIS OCCURRING BEFORE. THE LACK OF ANY BACKGROUND INFORMATION AND THE WORDING USED "SOMEONE BECAME CAUGHT IN THE MECHANISM" INDICATED THAT INVESTIGATION SHOULD TAKE A VERY WIDE VIEW OF WHAT COULD HAVE HAPPENED BEYOND THE KEY BODY PARTS AT RISK FOR ENTRAPMENT PER THE GUIDE LINES. PARTICULAR ATTENTION WAS GIVEN TO THE POSSIBILITY OF A FINGER(S) GETTING CAUGHT IN THE LATCH MECHANISM OR IN ANY OF THE MOVING COMPONENTS. WE COULD NOT DETERMINE ANY SCENARIO THAT WOULD BE CONSISTENT WITH THE EVENT REPORTED. WE WILL, OF COURSE, CONTINUE TO MONITOR CUSTOMER COMPLAINTS FOR ANY COMPLAINT EVEN SOMEWHAT SIMILAR BUT WHERE MORE BACKGROUND INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    PLEASE NOTE THE DATE LISTED IS THE DATE THE INCIDENT WAS REPORTED. THE ACTUAL DATE WAS NOT KNOWN BY THE REPORTER. THE FACILITY MAINTENANCE SUPERVISOR REPORTED THAT HE HAD HEARD THAT, AT ONE OF THE FACILITIES IN THE CHAIN OF LTC WHERE HE WORKS, SOMEONE HAD BECOME "CAUGHT IN THE MECHANISM OF A NOA SIDE RAIL AND THAT THE JAWS OF LIFE HAD TO BE USED TO FREE THE PERSON". THE REPORTER DID NOT KNOW IF THERE WERE ACTUAL INJURIES. THE TIME FRAME OF THE INCIDENT IS UNKNOWN. THE FACILITY IN THE CHAIN IS UNKNOWN. THE ORIGINAL REPORTER IS UNKNOWN. IT IS UNKNOWN IF THE PERSON CAUGHT IN THE MECHANISM WAS A RESIDENT, CARE GIVER, MAINTENANCE, OR OTHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN HOSPITAL BED SIDE RAIL FNJ NOA MEDICAL INDUSTRIES, INC UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention