BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SKLAR INSTRUMENTS

    MDR report key: 120762 · Received September 17, 1997

    Report

    Report Number
    120762
    Event Type
    Injury
    Date Received
    September 17, 1997
    Date of Event
    September 11, 1997
    Report Date
    September 17, 1997
    Manufacturer
    SKLAR INSTRUMENTS
    Product Code
    HDF
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ADDITIONAL INFO RECEIVED FROM MFR ON 10/08/1997: THE DEVICE HAS NOT PREVIOUSLY BEEN NOTED IN ANY INVESTIGABLE COMPLAINT OR MDR. THE DEVICE IS THREE YEARS IN SERVICE, CONSEQUENTLY ANY INITIAL DEFECT WOULD HAVE BEEN NOTED PREVIOUSLY. THE WEAR MENTIONED IS POSSIBLY THE RESULT OF MISHANDLING, THAT IS INAPPROPRIATE CONTACT WITH SOLID OBJECTS OR SURFACES POSSIBLY DURING STERILIZATION OR STORAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SKLAR INSTRUMENTS VAGINAL SPECULUM HDF SKLAR INSTRUMENTS PEDERSN, LARGE, BLUE *

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention 1. UTAH PRENDIVILLE LOOP| 2. ELECTROSURGICAL LOOP ELECTRODE 20MM X 12MM