BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KOH-EFFICIENT-RUMI

    MDR report key: 2485669 · Received March 7, 2012

    Report

    Report Number
    1216677-2012-00006
    Event Type
    Malfunction
    Date Received
    March 7, 2012
    Date of Event
    February 7, 2012
    Report Date
    March 5, 2012
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    LKF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE KOH-EFFICIENT-RUMI WAS NOT RETURNED TO COOPERSURGICAL FOR EVALUATION AND UNFORTUNATELY THE ACTUAL SIZE IS UNKNOWN. A QUERY OF OUR COMPLAINT DATABASE DID NOT REVEAL ANY TYPE OF PRODUCT TREND FOR PNEUMO BEING LOST DURING THE PROCEDURE. COOPERSURGICAL VISITED DR. (B)(6) FOR A DISCUSSION REGARDING THE KOH-EFFICIENT-RUMI AND IT WAS DETERMINED THAT THE VAGINAL LACERATIONS THAT REQUIRED SUTURING MAY HAVE BEEN RELATED TO THE CUP SIZE USED DURING THE PROCEDURE. (B)(4).

    Description of Event or Problem · 1

    WHILE USING THE KOH-EFFICIENT-RUMI THE DOCTOR REPORTED THAT PNEUMO HAD BEEN LOST AND THERE WERE VAGINAL LACERATIONS THAT HAD TO BE SUTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KOH-EFFICIENT-RUMI NONE LKF COOPERSURGICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1