BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOFLEX 35X84 DARTEX W/FB

    MDR report key: 2464346 · Received February 15, 2012

    Report

    Report Number
    1313850-2012-00042
    Event Type
    Injury
    Date Received
    February 15, 2012
    Date of Event
    January 18, 2012
    Report Date
    January 20, 2012
    Manufacturer
    STRYKER CORP DBA GAYMAR
    Product Code
    IKY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    MATTRESS NOT BEING RETURNED TO MANUFACTURER FOR EVALUATION; NO PRODUCT MALFUNCTION IS ALLEGED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT DEVELOPED A DEEP TISSUE INJURY WHILE ON THE MATTRESS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1