BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISOFLEX 35X84 SILVER W/FB

    MDR report key: 2397401 · Received November 22, 2011

    Report

    Report Number
    1313850-2011-00432
    Event Type
    Malfunction
    Date Received
    November 22, 2011
    Date of Event
    October 26, 2011
    Report Date
    October 27, 2011
    Manufacturer
    STRYKER CORP DBA GAYMAR
    Product Code
    IKY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSIONS: CUSTOMER HAS BEEN SENT A RENTAL UNIT WHILE INVESTIGATION IS CONDUCTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS FLUID INGRESS TO THE MATTRESS. NO PATIENT INVOLVEMENT OAR ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISOFLEX 35X84 SILVER W/FB MATTRESS IKY STRYKER CORP DBA GAYMAR 2800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1