BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOPATCH 3150

    MDR report key: 2842198 · Received November 15, 2012

    Report

    Report Number
    2648988-2012-00052
    Event Type
    Injury
    Date Received
    November 15, 2012
    Report Date
    November 15, 2012
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    FRO
    Adverse Event
    Yes
    Product Problem
    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 EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE REPORTER NOTED, "THE HOSPITAL REPORTED EXIT SITE INFECTION DUE TO THE USE OF BIOPATCH. FIVE DIALYSIS PTS WERE ON PERM CATHETERS ALONG WITH BIOPATCH AND THREE (OF THE FIVE) PTS WERE FOUND TO HAVE EXIT SITE INFECTIONS. THE HOSPITAL SUSPECTS BIOPATCH." ADD'L CLINICAL INFO WAS REQUESTED FROM THE REPORTING FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOPATCH 3150 NONE FRO INTEGRA NEUROSCIENCES PR 1122309

    Patients

    Seq Age Sex Outcome Treatment
    1