BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTINE TRANSBLEPH

    MDR report key: 2135703 · Received June 12, 2007

    Report

    Report Number
    3003644133-2007-00006
    Event Type
    Injury
    Date Received
    June 12, 2007
    Date of Event
    May 24, 2007
    Report Date
    May 24, 2007
    Manufacturer
    COAPT SYSTEMS, INC.
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PHYSICIAN PUT ONE PT ON ANTIBIOTICS AND AFTER A WEEK, THE INFECTION SUBSIDED. THE SECOND PT TOLD THE PHYSICIAN ABOUT THE INFECTION ON HER ONE WEEK FOLLOW-UP. THE INFECTION WAS CULTURED AND IS (B)(6). THE BATCH RECORD FOR THE LOT USED WAS REVIEWED AND NO ANOMALIES WERE NOTED. THE LOT PASSED LAL TESTING AND A CERTIFICATE OF STERILIZATION WAS RECEIVED FROM THE CONTRACT STERILIZER. A REVIEW OF THE LOT HISTORY FOUND THAT NO PREVIOUS COMPLAINTS, INCLUDING COMPLAINTS FOR INFECTION WERE RECEIVED FOR THIS LOT. IT WAS CONCLUDED THAT THE PT COULD HAVE DEVELOPED FLUID ACCUMULATION WHICH SECONDARILY BECAME CONTAMINATED IF THE PT HAD SOME (B)(6) IN THE THROAT OR ON THE SKIN. THE SPECIFIC CAUSE OF THE INFECTIOUS REACTION COULD NOT BE DETERMINED. NO LINKAGE BETWEEN THE USE OF THE DEVICE AND THE INFECTION WAS FOUND.

    Description of Event or Problem · 1

    PHYSICIAN PERFORMED AN ENDOTINE TRANSBLEPH PROCEDURE. IN THE FIRST WEEK AFTER SURGERY, TWO PTS HAD AN INTENSE INFLAMMATORY RESPONSE WITH A COPIOUS LIQUID/PUS DRAINAGE OUT OF THE OPERATIVE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTINE TRANSBLEPH SMOOTH METALLIC BONE FIXATION FASTENER HWC COAPT SYSTEMS, INC. CFD-080-0167 01570

    Patients

    Seq Age Sex Outcome Treatment
    1 Other