BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TARGIS SYSTEM

    MDR report key: 3116886 · Received May 16, 2013

    Report

    Report Number
    2133936-2013-00002
    Event Type
    Injury
    Date Received
    May 16, 2013
    Date of Event
    March 5, 2013
    Report Date
    April 17, 2013
    Manufacturer
    UROLOGIX, INC.
    Product Code
    MEQ
    PMA / PMN Number
    P970008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    UROLOGIX ORIGINALLY REPORTED: ON (B)(6) 2013, UROLOGIX INC. REGIONAL SALES DIRECTOR (RSD) REPORTED RECEIVING INFORMATION DURING A CONVERSATION WITH A PHYSICIAN THAT A PATIENT HAD PRESENTED WITH A BURN ON HIS SCROTUM AND THE BASE OF HIS PENIS FOLLOWING HIS MICROWAVE TREATMENT. NO ADDITIONAL INFORMATION WAS PROVIDED TO THE RSD AT THAT TIME. PRIOR TO FILING THE MDR, UROLOGIX UNSUCCESSFULLY ATTEMPTED TO CONTACT THE PHYSICIAN ON NUMEROUS OCCASIONS TO OBTAIN ADDITIONAL INVESTIGATIONAL INFORMATION. AFTER FILING THE MDR, UROLOGIX CONTINUED ATTEMPTING TO CONTACT THE PHYSICIAN. UROLOGIX WAS SUCCESSFUL IN CONTACTING THE PRESIDENT OF THE PRACTICE. THE PRESIDENT SAID HE WAS HOPEFUL THAT THE PATIENT WOULD BE OK AND THAT HE IS UNDER THE CARE OF A SPECIALIST. THE PRESIDENT PROVIDED NO FURTHER INFORMATION. A CHRONOLOGY OF PHYSICIAN CONTACT ATTEMPTS IS PROVIDED. THE TREATMENT DEVICE WAS NEVER RETURNED TO UROLOGIX FOR EVALUATION.

    Description of Event or Problem · 1

    ON (B)(6) 2013, UROLOGIX, INC. REGIONAL SALES DIRECTOR (RSD) REPORTED RECEIVING INFORMATION DURING A CONVERSATION WITH A PHYSICIAN THAT A PATIENT HAD PRESENTED WITH A BURN ON HIS SCROTUM AND THE BASE OF HIS PENIS FOLLOWING HIS MICROWAVE TREATMENT. NO ADDITIONAL INFORMATION WAS PROVIDED TO THE RSD AT THAT TIME. SINCE THE EVENT WAS INITIALLY REPORTED, UROLOGIX HAS ATTEMPTED CONTACT WITH THE PHYSICIAN TO OBTAIN ADDITIONAL INVESTIGATIONAL INFORMATION MORE THAN 12 TIMES WITH NO SUCCESS. UROLOGIX WILL CONTINUE TO CONTACT THE PHYSICIAN OFFICE AND WILL SUBMIT SUPPLEMENTS TO THE INITIAL MDR AS INFORMATION CAN BE OBTAINED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, UROLOGIX, INC. REGIONAL SALES DIRECTOR (RSD) REPORTED RECEIVING INFORMATION DURING A CONVERSATION WITH A PHYSICIAN THAT A PATIENT HAD PRESENTED WITH A BURN ON HIS SCROTUM AND THE BASE OF HIS PENIS FOLLOWING HIS MICROWAVE TREATMENT. NO ADDITIONAL INFORMATION WAS PROVIDED TO THE RSD AT THAT TIME. SINCE THE EVENT WAS INITIALLY REPORTED, UROLOGIX HAS ATTEMPTED CONTACT WITH THE PHYSICIAN TO OBTAIN ADDITIONAL INVESTIGATIONAL INFORMATION MORE THAN 12 TIMES WITH NO SUCCESS. UROLOGIX WILL CONTINUE TO CONTACT THE PHYSICIAN OFFICE AND WILL SUBMIT SUPPLEMENTS TO THE INITIAL MDR AS INFORMATION CAN BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216961 TARGIS SYSTEM MICROWAVE DELIVERY SYSTEM FOR BPH MEQ UROLOGIX, INC. TC1121C ACP10101811B

    Patients

    Seq Age Sex Outcome Treatment
    1 Other