BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFORMA STEREO

    MDR report key: 3839199 · Received May 15, 2014

    Report

    Report Number
    9610105-2014-00011
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    November 19, 2011
    Report Date
    April 16, 2014
    Manufacturer
    GE HEALTHCARE FINLAND OY
    Product Code
    IZH
    PMA / PMN Number
    K023864
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER WAS NOT PROVIDED.: THE INCIDENT OCCURRED IN 2011 BUT THE CUSTOMER ONLY INFORMED GE HEALTHCARE ON (B)(4) 2014, WHEN A FIELD ENGINEER WAS CALLED FOR SERVICE. THE CUSTOMER DOES NOT HAVE A SERVICE AGREEMENT WITH GE HEALTHCARE SINCE THE WARRANTY EXPIRED IN 2009, AND DID NOT REQUEST SERVICE IN 2011 AT THE TIME THE INCIDENT TOOK PLACE. THE EXACT DEVICE MANUFACTURE DATE IS UNKNOWN BUT THE SYSTEM WAS INSTALLED ON (B)(4) 2004. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A RUPTURED BREAST IMPLANT AFTER A MAMMOGRAPHY WITH A PERFORMA STEREO SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289422 PERFORMA STEREO SYSTEM, X-RAY, MAMMOGRAPHIC IZH GE HEALTHCARE FINLAND OY

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other