BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOGELAIR 84 X 35 X 6

    MDR report key: 3848088 · Received June 4, 2014

    Report

    Report Number
    0001831750-2014-03036
    Event Type
    Injury
    Date Received
    June 4, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 6, 2014
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    IOQ
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THEY WERE EXPERIENCING AN INCREASE IN DEEP TISSUE INJURIES AFTER INSTALLING THE ISOGEL AIR MATTRESSES IN THEIR ICU.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THEY WERE EXPERIENCING AN INCREASE IN DEEP TISSUE INJURIES AFTER INSTALLING THE ISOGEL AIR MATTRESSES IN THEIR ICU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326027 ISOGELAIR 84 X 35 X 6 BED, FLOTATION THERAPY, POWERED IOQ STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1