BEUDAMED
    FDA Adverse Event Other Summary report: N

    KC-RUMI-35 KOH-EFFICIENT, RUMI, 3.5 CM

    MDR report key: 4955925 · Received July 29, 2015

    Report

    Report Number
    1216677-2015-00041
    Event Type
    Other
    Date Received
    July 29, 2015
    Date of Event
    June 19, 2015
    Report Date
    June 19, 2015
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    LKF
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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.

    Description of Event or Problem · 1

    PER EMAIL COMPLAINT REQUEST FROM (B)(6), A PHYSICIAN REPORTED: "I'VE RETRIEVED THE ITEMS AND HAVE TAKEN THE PHOTOS (AS ATTACHED). FROM WHAT I OBSERVED, IT SEEMS THAT THE FRAGMENT GOT CHIPPED OFF THE EDGE OF THE KOH-CUP, DURING THE USE OF THE ESU UNIT. NO INJURY WAS CAUSED. HOWEVER, PLEASE LOOK INTO THIS ASAP AS THIS COULD POTENTIALLY BE A PROBLEM IF FRAGMENTS WERE NOT FOUND AND LEFT." REFERENCE E-COMPLAINT NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494571 KC-RUMI-35 KOH-EFFICIENT, RUMI, 3.5 CM KC-RUMI-35 KOH-EFFICIENT, RUMI, 3.5 CM LKF COOPERSURGICAL, INC. KC-RUMI-35 173507

    Patients

    Seq Age Sex Outcome Treatment
    1