BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUMI II,BACKLOADABLE

    MDR report key: 10466873 · Received August 28, 2020

    Report

    Report Number
    1216677-2020-00192
    Event Type
    Malfunction
    Date Received
    August 28, 2020
    Date of Event
    August 14, 2020
    Report Date
    August 28, 2020
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    LKF
    PMA / PMN Number
    K932115
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COOPER SURGICAL INC. IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION.

    Description of Event or Problem · 1

    REPORT STATED- "DR. (B)(6) WAS DOING CASE WITH ALLY AND THE UNIT BROKE . WAS UNABLE TO ANTIVER OR RETROVERT THE UTERUS." (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    933635 RUMI II,BACKLOADABLE RUMI II,BACKLOADABLE LKF COOPERSURGICAL, INC. UMH650 -

    Patients

    Seq Age Sex Outcome Treatment
    1 Other