BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALLEYLAB

    MDR report key: 3527687 · Received December 16, 2013

    Report

    Report Number
    MW5033495
    Event Type
    Injury
    Date Received
    December 16, 2013
    Date of Event
    December 13, 2013
    Report Date
    December 13, 2013
    Manufacturer
    COVIDIEN / VALLEYLAB
    Product Code
    FEH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    COVIDIEN VALLEYLAB SUCTION COAGULATOR, REF # (B)(4), LOT # S3DE016X, EXP 04/2018 - DEFECT IN PROTECTIVE SHEATH RESULTING IN BURN OF THE UPPER LIP DURING USE IN AN ADENOIDECTOMY CASE AT (B)(6) ON (B)(6) 2013. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656463 VALLEYLAB SUCTION COAGULATOR FEH COVIDIEN / VALLEYLAB 10FR/CH-6" S3DE016X

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR Required Intervention