BEUDAMED
    FDA Adverse Event Other Summary report: N

    SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

    MDR report key: 1754025 · Received July 9, 2010

    Report

    Report Number
    1220984-2010-00004
    Event Type
    Other
    Date Received
    July 9, 2010
    Date of Event
    May 5, 2010
    Report Date
    July 9, 2010
    Manufacturer
    HOLOGIC INC.
    Product Code
    MUE
    PMA / PMN Number
    P010025
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SELENIA SYSTEM WAS CHECKED BY AN HOLOGIC FIELD ENGINEER AND THE SYSTEM WAS FOUND TO MEET HOLOGIC SPECIFICATIONS. HOLOGIC TECHNICAL SUPPORT REVIEWED THE SYSTEM DATA LOG FILES FOR THIS PATIENT AND THE RECORDS SHOW THE EXPOSURES FOR THIS PARTICULAR PATIENT ARE WITHIN SPECIFICATION IN TERMS OF X-RAY TECHNIQUE AND EXPOSURE INDEX. DATA LOG: PROCEDURE 7444905. IMAGE 1: RLM 29KVP/ORGAN DOSE 1.81MGY/MAS61.9/ENTRANCE 7.18MGY/THICKNESS 3.5CM/COMPRESSION FORCE 141LBS/429 EXPOSURE INDEX. IMAGE 2: RCC 29/1.84/88.6/10.9/5.3/18/535. IMAGE 3: RLM 28/1.75/65.4/6.74/3.3/421. IMAGE 4: RCC 29/1.77/86.5/10.7/5.4/11/539. PROCEDURE 7444906. IMAGE 5: RCC 31/2.16/94.2/14.8/6.4/25/499. IMAGE 6: RML 32/2.66/135.8/18.2/7.7/41/484.

    Description of Event or Problem · 1

    A PATIENT REPORTED TO A USER FACILITY THAT THEY HAD A "RADIATION SKIN BURN". THIS PATIENT HAD A MAMMOGRAM AND NEEDLE LOCALIZATION PROCEDURE PERFORMED ON (B)(6) 2010. A SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM WAS USED FOR THIS PATIENT. NO OTHER INFORMATION WAS AVAILABLE ON THE PATIENT'S ALLEGED CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM MUE HOLOGIC INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1