BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUSTIN RETRACTOR

    MDR report key: 3193450 · Received June 21, 2013

    Report

    Report Number
    MW5030666
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Report Date
    June 21, 2013
    Manufacturer
    ACE SURGICAL
    Product Code
    EIG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    RI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, A (B)(6) FEMALE WAS HAVING A SURGICAL PROCEDURE FOR DENTAL EXTRACTIONS, DURING THE PROCEDURE, WHILE THE CHEEK RETRACTOR WAS IN THE PT'S MOUTH, THE CHEEK RETRACTOR WAS NOTED TO BE BROKEN WITH A CHIP MISSING FROM THE END. ALL PIECES WERE ACCOUNTED FOR. THE RETRACTOR WAS REMOVED FROM SURGICAL FIELD ALONG WITH BROKEN PIECE, MD AWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282506 AUSTIN RETRACTOR AUSTIN RETRACTOR EIG ACE SURGICAL 417-4002

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR