BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOGELAIR 84 X 35 X 6

    MDR report key: 3854320 · Received June 6, 2014

    Report

    Report Number
    0001831750-2014-03047
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 13, 2014
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FNM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP SUBMITTED WITH EVALUATION RESULTS PROVIDED BY CUSTOMER WHICH DID NOT ALLEGE A MALFUNCTION AND NO APPARENT MALFUNCTION WAS FOUND. CUSTOMER PERFORMED EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE USER FACILITY THAT THE PATIENT ALLEGEDLY DEVELOPED A DEEP TISSUE INJURY WHILE ON THE MATTRESS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE USER FACILITY THAT THE PATIENT ALLEGEDLY DEVELOPED A DEEP TISSUE INJURY WHILE ON THE MATTRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333157 ISOGELAIR 84 X 35 X 6 MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE FNM STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1