BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CALIBRATED LASIX BLADE (CLB) ML7070

    MDR report key: 4862286 · Received June 18, 2015

    Report

    Report Number
    2085081-2015-00001
    Event Type
    Malfunction
    Date Received
    June 18, 2015
    Date of Event
    May 21, 2015
    Report Date
    June 17, 2015
    Manufacturer
    MED-LOGICS, INC.
    Product Code
    HNO
    PMA / PMN Number
    K993225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BLADES SPECIFICATION HAS BEEN UPDATED TO INCREASE THE SURFACE AREA CONTACT BETWEEN THE BLADE AND BLADE HOLDER.

    Description of Event or Problem · 1

    PHYSICIAN NOTICED THE BLADE WAS EXTENDED TOO FAR OUT OF THE HEAD. BLADE WAS NOT USED ON PATIENT. PHYSICIAN OPENED ANOTHER BLADE AND WAS ABLE TO PUSH THE WHITE PLASTIC BLADE HOLDER RIGHT OFF THE BLADE WITH LITTLE TO NO EFFORT. HE THEN OPENED THREE MORE BLADES FROM THE SAME BOX AND THOSE BLADES HAD THE SAME ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396699 CALIBRATED LASIX BLADE (CLB) ML7070 MICROKERATOME BLADE HNO MED-LOGICS, INC. ML7070 1570081

    Patients

    Seq Age Sex Outcome Treatment
    1