BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UCHR POST, ANTERIOR

    MDR report key: 2706317 · Received August 16, 2012

    Report

    Report Number
    1222895-2012-00021
    Event Type
    Injury
    Date Received
    August 16, 2012
    Report Date
    August 16, 2012
    Manufacturer
    INTEGRA BURLINGTON, MA, INC.
    Product Code
    HAW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    THIS INCIDENT HAPPENED POST SURGERY IN THE DECONTAMINATION UNIT OF CENTRAL STERILE. THE EMPLOYEE WAS CLEANING THE ANTERIOR UCHR POST SYSTEM, HAND WASHING PER OUR INSTRUCTIONS, WHEN THE CARBON FIBER ANTERIOR HEAD RING POST SPLINTERED AND THE SPLINTER PUNCTURED HIS FINGER AND HAD TO BE REMOVED IN THE EMERGENCY ROOM. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UCHR POST, ANTERIOR NA HAW INTEGRA BURLINGTON, MA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1