BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOPATCH 3150

    MDR report key: 1527049 · Received November 11, 2009

    Report

    Report Number
    1121308-2009-00029
    Event Type
    Other
    Date Received
    November 11, 2009
    Date of Event
    October 9, 2009
    Report Date
    November 11, 2009
    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 EVAL. NO COMPLAINT SAMPLE LOT NUMBER WAS PROVIDED. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THERE WAS REDNESS AROUND THE BIOPATCH USED ON A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) INSERTION SITE IN THE LEFT ANTE CUBITAL FOSSA: THE SKIN WAS HARD AND TENDER TO THE TOUCH, THERE WAS ITCHING ALONG THE VEIN. REDNESS BEGAN WHEN THE BIOPATCH WAS APPLIED BY THE COMMUNITY NURSE ON AN UNK DATE. THE PICC LINE WAS SITED FOR FLUID ADMINISTRATION, BLOOD PRODUCTS, ANTIBIOTIC ADMINISTRATION AND BLOOD TESTING. THE PRODUCT WAS APPLIED AFTER CLEANSING WITH CHLORHEXIDINE THAT WAS ALLOWED DRY, AND WAS COVERED WITH IV3000 AND TEGADERM. THE PT WENT TO THE HOSPITAL ON (B)(6), 2009 AND REPORTED THAT THE BIOPATCH SITE WAS PAINFUL AND TENDER ON (B)(6), 2009. THE PICC LINE WAS REMOVED ON (B)(6), 2009 AND CREAM WAS APPLIED TO THE AFFECTED AREA AFTERWARDS. INTEGRA HAS REQUESTED ADDITIONAL CLINICAL INFO FROM THE REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOPATCH 3150 ANTIMICROBIAL PRODUCTS FRO INTEGRA NEUROSCIENCES PR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other