BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    909075

    MDR report key: 5612576 · Received April 27, 2016

    Report

    Report Number
    1216677-2015-00065
    Event Type
    Malfunction
    Date Received
    April 27, 2016
    Date of Event
    December 15, 2014
    Report Date
    October 2, 2015
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HGI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT AS PER REQUEST FROM FDA MEDWATCH PROGRAM. "THIS IS TO BRING TO YOUR ATTENTION THAT WE ARE IN RECEIPT OF SEVERAL SUPPLEMENT REPORTS SUBMITTED BY COOPER SURGICAL, INC., PLEASE BE INFORMED THAT THERE IS NO RECORD OF INITIAL REPORT SUBMISSIONS IN EMDR SYSTEM. IT APPEARS THAT FOLLOW-UP #1 COULD BE ACTUAL INITIAL REPORT BUT MAY HAVE BEEN ERRONEOUSLY SUBMITTED AS FOLLOW-UP IN ERROR. KINDLY VERIFY THE SUPPLEMENT REPORT AND RESUBMIT FOLLOW-UP #1 REPORT AS INITIAL REPORT ELECTRONICALLY THROUGH ESG WEBTRADER BY CHECKING ONLY "INITIAL" BOX IN AND ADVISE WHEN COMPLETE."

    Description of Event or Problem · 1

    REF E-COMPLAINT (B)(4). RETROSPECTIVE REVIEW - REFERENCE REPAIR LOG NUMBER 77090 PER REPAIR AUTHORIZATION FORM: " NO COAG ACTIVATION ."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269144 909075 909075 HGI COOPERSURGICAL, INC. 909075 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other