BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLVE

    MDR report key: 3813353 · Received March 28, 2014

    Report

    Report Number
    3010048749-2014-00043
    Event Type
    Malfunction
    Date Received
    March 28, 2014
    Report Date
    February 27, 2014
    Manufacturer
    ARJOHUNTLEIGH INC.
    Product Code
    IKY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PLEASE NOTE THAT PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED FROM THE MFR SITE KINETIC CONCEPTS, INC (UNDER REGISTRATION # (B)(4)). AS OF (B)(4) 2012, COMPLAINTS RELATED TO THIS PRODUCT ARE TO BE HANDLED BY ARJOHUNTLEIGH, INC AND REG #(B)(4). ADDITIONAL INFO WILL BE PROVIDED UPON CONCLUSION OF THE MFR INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE FOLLOWING WAS REPORTED TO ARJOHUNTLEIGH BY THE SUPPLY CHAIN MANAGER: 12 EVOLVE MATTRESSES ARE DEVELOPING A DEPRESSED ARE IN THE CENTER OF THE MATTRESS. IF THIS TYPE OF MALFUNCTION WERE TO RECUR, IT MAY CAUSE OR CONTRIBUTE TO THE SERIOUS INJURY OR MEDICAL INTERVENTION TO PREVENT HARM. THEREFORE, THIS EVENT IS REPORTABLE. THIS IS NUMBER 9 OF 12 EVENTS FOR THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185511 EVOLVE IKY ARJOHUNTLEIGH INC. PIQ-EV-DPV3584R

    Patients

    Seq Age Sex Outcome Treatment
    1