BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFORMA

    MDR report key: 2459822 · Received February 13, 2012

    Report

    Report Number
    3007120336-2012-00002
    Event Type
    Injury
    Date Received
    February 13, 2012
    Date of Event
    September 16, 2009
    Report Date
    October 1, 2009
    Manufacturer
    GE HUNGARY KFT
    Product Code
    IZH
    PMA / PMN Number
    K981641
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: THIS EVENT WAS ORIGINALLY REPORTED ON 10/30/2009 UNDER MDR 9611343-2009-00051. THE MANUFACTURING SITE LOCATION IS BEING CORRECTED FROM GE MEDICAL SYSTEMS (B)(4) TO GE (B)(4) (REGISTRATION NUMBER 3007120336). THIS REPORT (MDR 3007120336-2012-00002) REPLACES MDR 9611343-2009-00051. A GE FIELD ENGINEER (FE) WAS DISPATCHED TO THE SITE AND EVALUATED THE MAMMOGRAPHY SYSTEM. THE FE CHECKED THE COMPRESSION FORCE OF THE SYSTEM AND FOUND NO EVIDENCE OF PROBLEMS WITH THE SYSTEM. IN ADDITION TO VERIFYING THE COMPRESSION FORCE OF THE SYSTEM TO BE 12-16DAN, THE FIELD ENGINEER (FE) ALSO VERIFIED THAT THE SYSTEM'S MAXIMUM ALLOWABLE COMPRESSION WAS SET AT 18DAN. THE RESULTS OF THE INVESTIGATION SUGGESTED THAT THE SYSTEM WAS OPERATING ACCORDING TO SPECIFICATIONS AT THE TIME OF THE EVENT. THERE WAS NO EVIDENCE OF A RELATIONSHIP BETWEEN THE REPORTED PAIN AND SYSTEM PERFORMANCE. NO ADDITIONAL INFO REGARDING THE EVENT IS AVAILABLE.

    Description of Event or Problem · 1

    GE HEALTHCARE RECEIVED A REPORT FROM A PT FORWARDED BY THE CUSTOMER SITE. IN THE REPORT, THE PT INDICATED RECEIVING PAIN ON HER BREAST AFTER A MAMMOGRAM PROCEDURE USING THE PERFORMA SYSTEM. THE PT ALSO DESCRIBED FEELING NUMBNESS ON HER LEFT ARM AND TINGLING ON HER FINGERTIPS. THE PROCEDURE CONSISTED OF A 6 ACQUISITIONS WITH COMPRESSION FORCE RANGING FROM 12-16DAN. THE PT FURTHER REPORTED THAT 8 DAYS FROM THE TIME THE PROCEDURE WAS COMPLETED, SHE HAD BEEN TO A DOCTOR WHO CONFIRMED THAT HER NERVE HAD BEEN COMPRESSED. THE DOCTOR PRESCRIBED MEDICATION TO BE TAKEN FOR 5 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERFORMA IZH GE HUNGARY KFT

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other