BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNK

    MDR report key: 647623 · Received November 21, 2005

    Report

    Report Number
    1121308-2005-00033
    Event Type
    Other
    Date Received
    November 21, 2005
    Report Date
    November 21, 2005
    Manufacturer
    INTEGRA LIFESCIENCES
    Product Code
    FRO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE INTEGRA REP BECAME AWARE OF THE INCIDENT WHILE VISITING THE HOSP. A PT HAD A VERY NEGATIVE REACTION AFTER APPLICATION OF THE INTEGRA BILAYER WOUND DRESSING. THE PT SPIKED A FEVER AND HAD TO BE HOSPITALIZED. THE MEDICINES TAKEN BY THE PT WERE REPORTEDLY REVIEWED AND ONLY DIFFERENCE WAS THE APPLICATION OF THE PRODUCT. THE PT IS NOW FINE AND STABLE. IT IS UNK IF THE PT HAS A HYPERSENSITIVITY TO COLLAGEN. THE PRODUCT ID IS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK INTEGRA BILAYER MATRIX WOUND DRESSING FRO INTEGRA LIFESCIENCES * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention