BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HALOFLEX (115V) GENERATOR

    MDR report key: 2926166 · Received January 16, 2013

    Report

    Report Number
    3004904811-2013-00001
    Event Type
    Injury
    Date Received
    January 16, 2013
    Date of Event
    November 7, 2012
    Report Date
    December 18, 2012
    Manufacturer
    COVIDIEN/BARRX
    Product Code
    GEI
    PMA / PMN Number
    K092487
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SITE DID NOT RETURN ANY DEVICE THEREFORE AN ANALYSIS COULD NOT BE PERFORMED. IF ADDITIONAL INFO IS OBTAINED REGARDING THIS EVENT, A FOLLOW UP REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    THIS IS AN ADVERSE EVENT RECORDED ON A CRF AS PART OF THE (B)(6) REGISTRY. THIS PT WAS PROSPECTIVELY ENROLLED WITH 2 CM LOW GRADE DYSPLASIA. AFTER A THIRD FOCAL ABLATION, PT DEVELOPED DYSPHAGIA WITHIN 7-8 DAYS POST PROCEDURE. PER PHYSICIAN, ENDOSCOPY SHOWED SUPERFICIAL ULCERS, CAMERON EROSIONS AND ANTRAL EROSIONS; ALL PROBABLY NSAID (NON-STEROIDAL ANTI-INFLAMMATORY DRUG) INDUCED AND INCREASED WITH RFA EFFECT. ADDITIONALLY PER THE PHYSICIAN, THE SEVERITY OF THIS EVENT WAS MILD, THE RELATIONSHIP OF THE EVENT TO DEVICE PROCEDURE IS PROBABLE AND THERE WAS NO DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23654 HALOFLEX (115V) GENERATOR ELECTROSURGICAL COAGULATION SYSTEM GEI COVIDIEN/BARRX NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other 90-9100 HALO90 ALBATION CATHETER