BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SKLAR

    MDR report key: 6066335 · Received October 28, 2016

    Report

    Report Number
    MW5065681
    Event Type
    Injury
    Date Received
    October 28, 2016
    Date of Event
    June 6, 2016
    Report Date
    October 17, 2016
    Manufacturer
    SKLAR INSTRUMENTS
    Product Code
    EIG
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A LEEP PROCEDURE, THE PT WAS SOMEHOW BURNED. INSTRUMENTS INVOLVED INCLUDED: SKLAR LATERAL RETRACTOR #(B)(4), EURO-MED VAGINAL SPECULUM #(B)(4), EURO-MED TENACULUM #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714246 SKLAR LATERAL RETRACTOR EIG SKLAR INSTRUMENTS 91-5190
    714247 EURO-MED VAGINAL SPECULUM VAGINAL SPECULUM HIB COOPERSURGICAL, INC.
    714248 EURO-MED TENACULUM TENACULUM HGC COOPERSURGICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1