BEUDAMED
    FDA Adverse Event Other Summary report: N

    PROGENY

    MDR report key: 2031301 · Received March 24, 2011

    Report

    Report Number
    2438474-2011-00001
    Event Type
    Other
    Date Received
    March 24, 2011
    Date of Event
    March 15, 2011
    Report Date
    March 17, 2011
    Manufacturer
    PROGENY, INC.
    Product Code
    KPR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE ARE TWO PIECES, IDENTIFIED AS "COLLAR LOCKS", PROGENY (B)(4), PROVIDED WITH THE PROGENY LINEAR IV COLLIMATOR AS SHOWN IN THE ATTACHED PHOTOS (COLLIMATOR COLLAR LOCKS #1 AND COLLIMATOR COLLAR LOCKS #2) TAKEN OF A UNIT WE OPENED UP HERE IN OUR FACTORY. THE COLLAR LOCKS APPEAR TO BE MISSING FROM THE COLLIMATOR SHOWN IN (B)(6) PICTURES WE RECEIVED. THE COLLAR LOCKS, ACCORDING TO PROGENY, ARE "FAIL-SAFES" IN THE EVENT THE COLLAR/SCREW ASSEMBLY BECOMES DETACHED, AS IN THIS INCIDENT. THE COLLIMATOR IS SHIPPED WITH THESE PARTS INSTALLED, AND MUST BE REMOVED AND RE-INSTALLED BY THE FIELD SERVICE TECHNICIAN ACCORDING TO THE MANUFACTURER'S INSTRUCTIONS.

    Description of Event or Problem · 1

    EVENT DESC: TECH WHILE ALIGNING COLLIMATOR TO TAKE IMAGE, COLLIMATOR CAME LOOSE AND FELL ON PATIENT'S HAND. TECH BROKE FALL OF COLLIMATOR, PATIENT GOT CUT ABOUT .5" LONG. SECOND SET OF X-RAYS TO ENSURE NO FURTHER HARM. NOT SURE WHICH HAND. HOSPITAL CANNOT RELEASE PATIENT INFO DUE TO HIPPA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGENY X-RAY COLLIMATOR KPR PROGENY, INC. LINEAR IV NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA