BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROBE COVER

    MDR report key: 3928380 · Received June 18, 2014

    Report

    Report Number
    8043817-2014-00003
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    May 28, 2014
    Report Date
    June 18, 2014
    Manufacturer
    MICROTEK MEDICAL, INC.
    Product Code
    KKX
    PMA / PMN Number
    K882724
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4), A MEETING REGARDING THE ISSUE TOOK PLACE ON (B)(4) 2014 WAS CONDUCTED BY REGULATORY AFFAIRS, QUALITY, AND RD STAFFS. AFTER REVIEWING HISTORICAL RECORDS OF THE PRODUCT WITH ANALYSIS ON THE PRODUCT, SOLD IN THE MARKET; IT WAS CONCLUDED THAT THERE WERE NO COMPLAINTS OR ADVERSE EVENTS DOCUMENTED IN THE PAST. IT IS CONCLUDED THAT THE ROOT CAUSE FOR THIS INCIDENT JUST AN ISOLATED EVENT. AFTER OUR INVESTIGATION, ECOLAB WILL KEEP DESIGN OF THE PRODUCT THE SAME. THE DEVICE WILL BE SAFE AND EFFECTIVE ACCORDING TO THE RISK ANALYST RECORDS.

    Description of Event or Problem · 1

    ON (B)(6) 2014 - ECOLAB RECEIVED AN EMAIL FROM (B)(6) REGARDING THE PRODUCT NUMBER PC3787 INOPERATIVE ULTRASOUND PROBE COVERS. THE HOSPITAL STAFF FOUND THE STICKY TAPE WAS LOOSE AND FLOATING AROUND THE CAVITY. WHEN THE HOSPITAL STAFF PULLED THE RUBBER BAND OFF THE PROBE COVER, THE STICKY BLUE TAPS THAT SHOULD STAY ON THE COVER WAS LOOSE AND FLOATING AROUND THE CAVITY. THE STICKY BLUE TAPS SHOULD REMAIN ADHERED TO THE PROBE COVER FOR SECURING PURPOSES. THE STICKY BLUE TAPS COULD HAVE REMAINED IN THE HUMAN BODY IF NO ONE FROM THE HOSPITAL NOTICED THE BLUE TAPS FLOATING THE PROBE COVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356745 PROBE COVER LATEX FREE PROBE COVER WITH GEL KKX MICROTEK MEDICAL, INC. NA D133341

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK