BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLVE

    MDR report key: 3900231 · Received May 2, 2014

    Report

    Report Number
    3010048749-2014-00056
    Event Type
    Malfunction
    Date Received
    May 2, 2014
    Report Date
    January 24, 2014
    Manufacturer
    ARJOHUNTLEIGH, INC.
    Product Code
    IKY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED FROM THE MANUFACTURING SITE KINETIC CONCEPTS, INC. AS OF (B)(6) 2012, COMPLAINTS RELATED TO THIS PRODUCT ARE TO BE HANDLED BY ARJOHUNTLEIGH, INC. ADDITIONAL INFORMATION WILL BE PROVIDED UPON CONCLUSION OF THE MANUFACTURER INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE FOLLOWING WAS REPORTED TO ARJOHUNTLEIGH BY THE FACILITY: THERE WERE A TOTAL OF 20 MATTRESSES THAT WERE RETURNED DUE TO DEFORMATION IN THE MID-SECTION. THIS IS COMPLAINT NUMBER 2 OF 20. THERE WAS NO INJURY ASSOCIATED WITH THIS COMPLAINT. THIS IS BEING REPORTED WITH AN ABUNDANCE OF CAUTION AS IF THIS TYPE OF MALFUNCTION WERE TO RECUR, IT MAY CAUSE OR CONTRIBUTE TO DEATH, SERIOUS INJURY OR MEDICAL INTERVENTION TO PREVENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266216 EVOLVE IKY ARJOHUNTLEIGH, INC. KEV-DPNB-3584

    Patients

    Seq Age Sex Outcome Treatment
    1