BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABRAMS BIOPSY NEEDLE

    MDR report key: 3038035 · Received April 1, 2013

    Report

    Report Number
    1213649-2013-00016
    Event Type
    Malfunction
    Date Received
    April 1, 2013
    Date of Event
    January 31, 2012
    Report Date
    January 31, 2013
    Manufacturer
    CADENCE INC.
    Product Code
    FCG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CADENCE ACKNOWLEDGES THIS REPORT DOES NOT MEET THE THIRTY DAY REPORTING REQUIREMENTS. THIS WAS UNINTENTIONAL. THIS REPORT IS BEING FILED AFTER IT WAS IDENTIFIED AS NON-COMPLIANT DURING AN INTERNAL REVIEW OF OUR COMPLAINT FILES.

    Description of Event or Problem · 1

    ON (B)(6) 2012, IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE THE NEEDLE BROKE AFTER 3-4 USES. NO INFO WAS AVAILABLE ON WHETHER THE PROCEDURE WAS COMPLETED. IF ADD'L INFO IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132580 ABRAMS BIOPSY NEEDLE NEEDLE FCG CADENCE INC. 8040 59049-01

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other