BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOFLEX 35X84 DARTEX W/FB

    MDR report key: 2885113 · Received December 13, 2012

    Report

    Report Number
    1313850-2012-00372
    Event Type
    Injury
    Date Received
    December 13, 2012
    Date of Event
    November 19, 2012
    Report Date
    November 19, 2012
    Manufacturer
    STRYKER CORP DBA GAYMAR
    Product Code
    FNM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT'S SKIN BROKE DOWN WHILE ON THE MATTRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISOFLEX 35X84 DARTEX W/FB MATTRESS FNM STRYKER CORP DBA GAYMAR 2800000000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1