BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOPATCH ANTIMICROBIAL DRESSING, 1" DISK

    MDR report key: 1053093 · Received May 23, 2008

    Report

    Report Number
    2648988-2008-00026
    Event Type
    Other
    Date Received
    May 23, 2008
    Date of Event
    May 1, 2008
    Report Date
    May 23, 2008
    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 AVAILABLE FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED, BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) WAS PLACED IN THE ANTE CUBITAL FOSSA AREA OF THE ARM OF A PREMATURE BABY GIRL, BORN AT 28 WEEKS GESTATION. AFTER 4 DAYS, THE SITE WAS NOTICED TO BE LEAKING; NO LEAKING WAS REPORTED FROM THE LINE. THE PATIENT'S ENTIRE ARM TURNED RED, A PHOTOGRAPH SHOWS REDNESS WITH APPARENT SKIN LOSS IN AN AREA EXTENDING FROM THE ELBOW CREASE TO THE MID FOREARM. THE PICC WAS REMOVED FROM THE SITE AND A NEW PICC WAS PLACED IN THE OTHER ARM WITH NO BIOPATCH DRESSING. THE AFFECTED ARM WAS TREATED WITH BACTROBAN AND THE SYMPTOMS RESOLVED. THE BABY RECOVERED FROM THE EVENT, AND WAS DISCHARGED FROM THE UNIT. THE INSTRUCTIONS FOR USE OF THE DEVICE STATE: WARNINGS: DO NOT USE BIOPATCH DRESSING ON PREMATURE INFANTS, USE OF THIS PRODUCT ON PREMATURE INFANTS HAS RESULTED IN HYPERSENSITIVITY REACTIONS AND NECROSIS OF THE SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOPATCH ANTIMICROBIAL DRESSING, 1" DISK ANTIMICROBIAL DRESSING FRO INTEGRA NEUROSCIENCES, PR 1073082

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention