BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 1122563 · Received August 14, 2008

    Report

    Report Number
    1122563
    Event Type
    Injury
    Date Received
    August 14, 2008
    Date of Event
    April 14, 2008
    Report Date
    July 22, 2008
    Manufacturer
    ALBAHEALTH LLC DIV
    Product Code
    GAD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A SCREW WAS MISSING FROM THE BALFOUR RETRACTOR. AN X-RAY WAS OBTAINED TO ENSURE THAT THE SCREW WAS NOT IN PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * BALFOUR RETRACTOR GAD ALBAHEALTH LLC DIV UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention