BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETRACTOR RINGS

    MDR report key: 1913142 · Received November 15, 2010

    Report

    Report Number
    1913142
    Event Type
    Malfunction
    Date Received
    November 15, 2010
    Date of Event
    November 11, 2010
    Report Date
    November 15, 2010
    Manufacturer
    LONE STAR MEDICAL PRODUCTS
    Product Code
    GAD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US

    Narratives

    Description of Event or Problem · 1

    DURING THE CASE, A PIECE OF THE LONESTAR RETRACTOR BROKE OFF. THE PIECE WAS RETRIEVED & EXAMINED BY PHYSICIAN. AN INTRA-OPERATIVE X-RAY WAS TAKEN AS A SAFETY PRECAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RETRACTOR RINGS RETRACTOR RINGS GAD LONE STAR MEDICAL PRODUCTS 3307G 88504

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR