BEUDAMED
    FDA Adverse Event Other Summary report: N

    VANGUARD BREAST MRI AUXILIARY TABLE WITH 8CH

    MDR report key: 3452895 · Received October 25, 2013

    Report

    Report Number
    3005748597-2013-00003
    Event Type
    Other
    Date Received
    October 25, 2013
    Date of Event
    October 11, 2013
    Report Date
    October 24, 2013
    Manufacturer
    SENTINELLE MEDICAL, INC.
    Product Code
    MOS
    PMA / PMN Number
    K060873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE HEALTHCARE FIELD ENGINEER (FE) WAS DISPATCHED TO AFFECTED SITE. THE FE REPORTED THAT THE LEFT DRAWER SLIDE HAD PULLED OVER ITS MECHANICAL STOP AND THE RIGHT DRAWER SLIDE WAS BENT AND HAD COMPLETELY BROKEN APART. BOTH SLIDE ASSEMBLIES TO BE REPLACED.

    Description of Event or Problem · 1

    THIS ADVERSE EVENT WAS REPORTED BY THE GE CLINICAL PRODUCT SURVEILLANCE SPECIALIST ((B)(4)) AS SUCH: "ON THURSDAY THE LEAD TECH PULLED THE SENTINELLE MAMMO TABLE'S LOWER ACCESSORY DRAWER OUT AND IT FELL ON HER FOOT. HER FOOT WAS INJURED BUT DID NOT REQUIRE MEDICAL TREATMENT." GE HEALTHCARE HAS CONTACTED THE SITE 3 ADD'L TIMES TO OBTAIN MORE INFO ON THE EXTENT OF THE FOOT INJURY AND TO SEE IF PT FOLLOW-UP IS REQUIRED. SITE HAS NOT RESPONDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548403 VANGUARD BREAST MRI AUXILIARY TABLE WITH 8CH COIL, MAGNETIC RESONANCE, SPECIALTY MOS SENTINELLE MEDICAL, INC. 4000001-11

    Patients

    Seq Age Sex Outcome Treatment
    1 Other