BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROAIRE

    MDR report key: 4173288 · Received September 26, 2014

    Report

    Report Number
    2020601-2014-00078
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    May 10, 2013
    Report Date
    September 25, 2014
    Manufacturer
    MICROAIRE SURGICAL INSTRUMENTS
    Product Code
    HWC
    PMA / PMN Number
    K863734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER A RECENT FDA INSPECTION, MICROAIRE MODIFIED OUR MDR REPORTING CRITERIA AND HAVE DETERMINED THIS SHOULD HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    A RECALLED K-WIRE WAS IMPLANTED ON (B)(6) 2013; PT ACQUIRED INFECTION; ANTIBIOTICS STARTED; K-WIRE PULLED OUT ON (B)(6) 2013 WITH PUSTULAR DRAINAGE PER PHYSICIAN; PT ADMITTED TO HOSP FOR I&D OF LEFT FOOT ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600667 MICROAIRE K-WIRE HWC MICROAIRE SURGICAL INSTRUMENTS 1600-645 0313218305

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention