BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SUNNYVALE PRODUCT

    MDR report key: 4750555 · Received May 5, 2015

    Report

    Report Number
    3004904811-2015-00007
    Event Type
    Injury
    Date Received
    May 5, 2015
    Date of Event
    November 20, 2014
    Report Date
    May 5, 2015
    Manufacturer
    COVIDIEN
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SITE INDICATED THAT THE INCIDENT UNIT WOULD NOT BE RETURNING FOR EVALUATION. IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    A PATIENT UNDERWENT RADIOFREQUENCY ABLATION (RFA) AS A PARTICIPANT IN THE B-600 RGB SALVAGE STUDY. THE PATIENT REPORTED NAUSEA AND VOMITING FOR FIVE WEEKS AFTER ABLATION. THE TREATING PHYSICIAN PERFORMED AN UPPER ENDOSCOPY (EGD) SEVEN WEEKS POST RFA WHICH REVEALED A STENOSED GASTRIC POUCH, WHICH WAS DILATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295079 UNKNOWN SUNNYVALE PRODUCT UNKNOWN RFA GEI COVIDIEN UNKNOWN RFA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention