BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8.0 FR W/VITACUFF

    MDR report key: 935584 · Received October 29, 2007

    Report

    Report Number
    1720496-2007-00226
    Event Type
    Injury
    Date Received
    October 29, 2007
    Date of Event
    October 5, 2007
    Report Date
    October 15, 2007
    Manufacturer
    C.R. BARD, INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K831386
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A CHR REVIEW SHOWED NO OTHER SIMILAR PRODUCT COMPLAINANT FILE(S) FROM THIS LOT.

    Description of Event or Problem · 1

    SITE WHERE GROSHONG CATHETER WAS PULLED HAS SLOW/DELAYED HEALING. EVENTUALLY HAD DRAINAGE. PATIENT WAS TREATED FOR INFECTION. WHILE CLEANING INFECTION SITE FATHER REPORTS A SMALL ROLL OF "GAUZE" CAME OUT OF INFECTION SITE. ADDITIONAL INFORMATION PROVIDED BY THE COMPLAINANT: THE CATHETER HAD BEEN REMOVED BECAUSE THE PATIENT NO LONGER REQUIRED IT FOR ANTIBIOTICS, THE PHYSICIAN THAT REMOVED IT FELT THAT ALL THE LINE HAD BEEN REMOVED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8.0 FR W/VITACUFF LJS C.R. BARD, INC. (BASD) RERA0511

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention