BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOPATCH 4150

    MDR report key: 1943824 · Received December 22, 2010

    Report

    Report Number
    2648988-2010-00098
    Event Type
    Other
    Date Received
    December 22, 2010
    Date of Event
    December 15, 2010
    Report Date
    December 22, 2010
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    FRO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT EXPECTED TO BE RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE RPTR STATED THAT THE BIOPATCH WAS PLACED ON A BROVIAC LINE ON (B)(6) 2010, AND FOUR DAYS LATER, THE PT COMPLAINED OF PAIN AT THE SITE. THE DRESSING WAS REMOVED AND THE SITE WAS PINK AND GREENISH WHITE. NO CULTURES WERE PERFORMED OF THE SITE AND TWO DAYS LATER, THE LINE WAS REMOVED DUE TO LEAKING. CHLORPROP WAS USED TO CLEANSE THE SKIN. IT WAS ALLOWED TO DRY AND TEGADERM WAS PLACED OVER THE DRESSING. THE PT IS ON THE WAITING LIST FOR A HEART TRANSPLANT AND THIS WAS THE FIRST TIME BIOPATCH WAS USED ON THE PT. THE CENTRAL LINE WAS USED FOR INFUSION OF HEPARIN AND MILRINONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOPATCH 4150 BIOPATCH FRO INTEGRA NEUROSCIENCES PR 1102093

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR