BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BELLA BLANKETS

    MDR report key: 2632110 · Received June 4, 2012

    Report

    Report Number
    9021987-2012-00001
    Event Type
    Malfunction
    Date Received
    June 4, 2012
    Date of Event
    November 22, 2012
    Report Date
    May 31, 2012
    Manufacturer
    BEEKLEY CORPORATION
    Product Code
    IZH
    PMA / PMN Number
    K073262
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    (B)(4) PROTECTIVE COVERLETS CONTAINED A MATERIAL COMPONENT WHICH COULD HAVE IMAGED AS ARTIFACT ON A PT MAMMOGRAM. THIS COMPONENT OF THE PRODUCT CAUSED A HONEYCOMB OR DIAMOND-LOOKING PATTERN ARTIFACT TO APPEAR ON 2 PATIENT IMAGES WHICH WAS NOTICED BY THE RADIOLOGIST, RESULTING IN 2 REPEAT MAMMOGRAM IMAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BELLA BLANKETS X-RAY SYSTEM, MAMMOGRAPHY IZH BEEKLEY CORPORATION 311 107657, 108-833/850

    Patients

    Seq Age Sex Outcome Treatment
    1