BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    J NEEDLE SET

    MDR report key: 3038037 · Received April 1, 2013

    Report

    Report Number
    1213649-2013-00014
    Event Type
    Malfunction
    Date Received
    April 1, 2013
    Date of Event
    July 12, 2011
    Report Date
    July 12, 2011
    Manufacturer
    CADENCE INC.
    Product Code
    DWO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NOT APPLICABLE

    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. WHILE THE ACTUAL DEVICE WAS NOT RETURNED FOR EVALUATION, THE REPORTED NEEDLE BENT WAS CONFIRMED BY PHOTOGRAPHIC EVIDENCE. THE CAUSE OF THE NEEDLE BENT COULD NOT BE DETERMINED FROM THE PHOTOGRAPH.

    Description of Event or Problem · 1

    ON (B)(6) 2011, IT WAS REPORTED THAT DURING A PROCEDURE THE NEEDLE BENT. 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
    132372 J NEEDLE SET NEEDLE DWO CADENCE INC. 7836 73676-03

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK