BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRIADYNE PROVENTA

    MDR report key: 3397022 · Received October 1, 2013

    Report

    Report Number
    3010048749-2013-00029
    Event Type
    Other
    Date Received
    October 1, 2013
    Date of Event
    September 27, 2013
    Report Date
    September 27, 2013
    Manufacturer
    ARJOHUNTLEIGH, INC.
    Product Code
    IKZ
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF (B)(4) 2012, COMPLAINTS RELATED TO THIS PRODUCTS ARE TO BE HANDLED BY ARJOHUNTLEIGH INC. ADD'L INFO WILL BE PROVIDED UPON CONCLUSION OF THE MFR'S INVESTIGATION.

    Description of Event or Problem · 1

    THE FOLLOWING INFO WAS REPORTED TO ARJOHUNTLEIGH BY THE NURSE: ON (B)(6) 2013, WHILE TURNING THE PT, IT WAS NOTED THAT THERE WAS A RED MARK ON THE PT'S RIGHT LOWER FLANK AREA. THE RED MARK WAS APPROX 4CM LONG BY 2CM WIDE AND ASSESSED AS A STAGE I PRESSURE ULCER. AFTER EXAMINING THE BED IT WAS DETERMINED THERE WAS A LARGE SCREWDRIVER WEDGED BETWEEN THE AIR CUSHIONS OF THE MATTRESS. IT WAS NOT KNOWN HOW THE SCREWDRIVER GOT THERE. THE SCREWDRIVER WAS REMOVED AND THE PT MOVED TO A DIFFERENT BED. THE NURSE STATED THAT THE STAGE I PRESSURE ULCER WAS RESOLVING WITHOUT ANY MEDICAL INTERVENTION AND THE PT WAS DOING WELL. THIS IS BEING REPORTED AS IF THIS SITUATION WERE TO RECUR, THERE IS A POTENTIAL FOR SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494497 TRIADYNE PROVENTA IKZ ARJOHUNTLEIGH, INC. 308900

    Patients

    Seq Age Sex Outcome Treatment
    1