BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE INDUSTRIES

    MDR report key: 2192703 · Received July 14, 2011

    Report

    Report Number
    1058746-2011-00001
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    March 9, 2007
    Report Date
    July 13, 2011
    Manufacturer
    UNIMED SURGICAL PRODUCTS, INC.
    Product Code
    GEI
    PMA / PMN Number
    K962935
    Removal / Correction Number
    NONE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L LOT #: 121106-01. STICKING OF TISSUE DURING THE USE OF ELECTROSURGICAL ELECTRODES IS A KNOWN RISK IN THESE DEVICES. THIS INCIDENT CAUSED NO SERIOUS INJURY AND REQUIRED NO PHYSICIAN INTERVENTION. THIS PRODUCT WAS SUPPLIED BULK, NON-STERILE.

    Description of Event or Problem · 1

    TWO DIFFERENT DOCTORS HAVE REPORTED THE SAME EXPERIENCE WITH THE CAUTERY TIP. DURING PROCEDURES, TISSUE IS STICKING TO THE TIP AND PULLING AWAY AT SKIN CAUSING EXCESSIVE BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDLINE INDUSTRIES 2.75" STD COATED BLADE (EMRALON COATED) GEI UNIMED SURGICAL PRODUCTS, INC. NA 021306-01

    Patients

    Seq Age Sex Outcome Treatment
    1