BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KMEDIC SISTRUNK SCISSORS CURVED

    MDR report key: 1547736 · Received November 18, 2009

    Report

    Report Number
    3005236665-2009-00008
    Event Type
    Malfunction
    Date Received
    November 18, 2009
    Report Date
    September 25, 2009
    Manufacturer
    KMEDIC EUROPE GMBH
    Product Code
    HRR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE REQUESTED BUT NOT RECEIVED YET. INVESTIGATION IS ONGOING AND A FOLLOW-UP REPORT WILL BE ISSUED WHEN COMPLETED.

    Description of Event or Problem · 1

    INCIDENT REPORTED AS: THE TIP OF THE SCISSORS BROKE DURING SURGERY. THE SURGEON LOCATED THE BROKEN PIECE. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KMEDIC SISTRUNK SCISSORS CURVED CURVED SCISSORS HRR KMEDIC EUROPE GMBH 04/1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA