BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTISEAL VALVED PTFE PEELABLE INTRODUCER

    MDR report key: 3770292 · Received February 18, 2014

    Report

    Report Number
    2183787-2014-00028
    Event Type
    Malfunction
    Date Received
    February 18, 2014
    Date of Event
    September 27, 2013
    Report Date
    February 5, 2014
    Manufacturer
    GREATBACH MEDICAL .
    Product Code
    DYB
    PMA / PMN Number
    K093232
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    N/A

    Description of Event or Problem · 1

    RIGHT AFTER THE OPTISEAL INTRODUCER WAS SPLIT, IT WAS NOTICED THAT THERE WAS A STRING OF PLASTIC THAT WAS INSIDE OF THE INTRODUCER. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101117 OPTISEAL VALVED PTFE PEELABLE INTRODUCER OPTISEAL VALVED PTFE PEELABLE INTRODUCER DYB GREATBACH MEDICAL . 1000093-004 W2221841

    Patients

    Seq Age Sex Outcome Treatment
    1 Other