BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOSEAL ENDOSCOPIC APPLICATOR

    MDR report key: 1078919 · Received July 17, 2008

    Report

    Report Number
    2954761-2008-00037
    Event Type
    Malfunction
    Date Received
    July 17, 2008
    Date of Event
    June 26, 2008
    Report Date
    July 16, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    LMF
    PMA / PMN Number
    P990009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). PMA NUMBER/SUPPLEMENT: P990009/S16/A1. THIS IS BEING REPORTED TO THE AGENCY AS A CONSERVATIVE MEASURE. ALTHOUGH NO SAMPLE IS AVAILABLE FROM THE REPORTER, WE HAVE LAUNCHED AN INVESTIGATION INTO THIS CASE AND WILL UPDATE THE AGENCY WITH THE INVESTIGATION FINDINGS AS SOON AS POSSIBLE.

    Description of Event or Problem · 1

    CUSTOMER STATED ENDOSCOPIC FLOSEAL APPLICATOR SPLIT DURING SURGERY AND CAUSED FLOSEAL SEALANT TO CHANGE ITS COLORATION. ADDITIONAL INFO RECEIVED - THE APPLICATOR DID NOT SPLIT, AND THE PRODUCT CHANGED TO A GRAYISH SILVER COLOR WHEN PUSHED THROUGH THE OTHER END OF THE APPLICATOR. THE DISCOLORATION WAS NOT PRESENT PRIOR TO INSERTING THE FLOSEAL INTO THE APPLICATOR. THE PRODUCT WAS NOT USED ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLOSEAL ENDOSCOPIC APPLICATOR LMF BAXTER HEALTHCARE NA 08C076

    Patients

    Seq Age Sex Outcome Treatment
    1