BEUDAMED
    FDA Adverse Event Summary report: N

    SKLAR BLUE

    MDR report key: 321378 · Received March 16, 2001

    Report

    Report Number
    MW1021355
    Date Received
    March 16, 2001
    Date of Event
    February 28, 2001
    Manufacturer
    SKLAR INSTRUMENTS
    Product Code
    HDF
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BURNS OCCURRED TO THE VAGINAL LINING OF THE PT DURING A LEEP PROCEDURE. BOVIE USED WAS CHECKED AND FOUND TO BE FUNCTIONING APPROPRIATELY. SPECULUM USED HAS AN INSULATED COATING IN ALL AREAS EXCEPT THE TIGHTENING SCREW.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 4/24/01: MFR HAS REQUESTED COPIES OF ALL OF THE DOCUMENTATION GENERATED FROM THE INCIDENT. ONCE MFR IS IN RECEIPT OF THIS INFO IT WILL INVESTIGATE THE MATTER WITHOUT THE DEVICE. THE DEVICE IS BEING HELD AT THE HOSP AND IS NOT AVAILABLE TO MFR FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11971 SKLAR BLUE VAGINAL SPECULUM, SKLER BLUE HDF SKLAR INSTRUMENTS UNK *

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR