BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CU-1 HER OPTION CONTROL UNIT

    MDR report key: 5614270 · Received April 28, 2016

    Report

    Report Number
    1216677-2016-00000
    Event Type
    Injury
    Date Received
    April 28, 2016
    Date of Event
    December 30, 2015
    Report Date
    January 11, 2016
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    GEH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL INC. IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION. THE DEVICE INVOLVED IN THE COMPLAINT HAS NOT BEEN RETURNED BY THE CUSTOMER FOR EVALUATION. ONCE THE INVESTIGATION IS COMPLETED A FOLLOW-UP REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    "MY PARTNER DID HEROPTION 1 WK AGO AND PT WAS HOSPITALIZED FOR SEPSIS DUE TO PERFORATION." (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272545 CU-1 HER OPTION CONTROL UNIT CU-1 HER OPTION CONTROL UNIT GEH COOPERSURGICAL, INC. CU-1 190440

    Patients

    Seq Age Sex Outcome Treatment
    1 Other