BEUDAMED
    FDA Adverse Event No answer provided Summary report: N

    DRIVE

    MDR report key: 15015277 · Received July 14, 2022

    Report

    Report Number
    2438477-2022-00065
    Event Type
    No answer provided
    Date Received
    July 14, 2022
    Date of Event
    May 3, 2022
    Report Date
    July 14, 2022
    Manufacturer
    POLIURETANOS, S.A. DE C.V.
    Product Code
    IKY
    UDI-DI
    00822383516431
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    DRIVE DEVILBISS HEALTHCARE WAS CONTACTED REGARDING A REPORTED INJURY INVOLVING A PRESSURE REDISTRIBUTION FOAM MATTRESS, WHICH IS INTENDED TO BE USED AS ONE COMPONENT OF A COMPREHENSIVE, MULTI-DISCIPLINARY PRESSURE INJURY MANAGEMENT PROGRAM. THE END USER, WHO IS BEDRIDDEN, REPORTED HAVING DEVELOPED BED SORES AFTER 8 MONTHS OF USE, REPORTEDLY DUE TO THE MATTRESS BECOMING VERY HOT. DRIVE DID NOT RECEIVE ANY INFORMATION REGARDING THE PATIENT'S OVERALL PRESSURE INJURY MANAGEMENT PROGRAM. DRIVE IS CURRENTLY INVESTIGATING THE INCIDENT, INCLUDING ATTEMPTING TO RETRIEVE THE PRODUCT TO EVALUATE IT. DRIVE WILL UPDATE THIS FILING IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2350050 DRIVE PRESSURE REDISTRIBUTION FOAM MATTRESS IKY POLIURETANOS, S.A. DE C.V. 6500-DE-2-FB 00822383516431

    Patients

    Seq Age Sex Outcome Treatment
    1 Female