BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEOTRACT UROLIFT SYSTEM

    MDR report key: 20463126 · Received October 16, 2024

    Report

    Report Number
    3015181082-2024-00027
    Event Type
    Injury
    Date Received
    October 16, 2024
    Date of Event
    July 8, 2024
    Report Date
    October 16, 2024
    Manufacturer
    NEOTRACT, INC.
    Product Code
    PEW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS IT WAS REPORTED THAT THE SAMPLE IS NOT AVAILABLE FOR RETURN. A DEVICE HISTORY RECORD REVIEW COULD NOT BE CONDUCTED SINCE THE LOT NUMBER OF THE DEVICE WAS NOT PROVIDED. WITHOUT THE DEVICE TO EVALUATE THE COMPLAINT COULD NOT BE CONFIRMED AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. IF THE SAMPLE BECOMES AVAILABLE AT A LATER DATE A FOLLOW-UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS. NEOTRACT, INC. WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

    ON SEPTEMBER 17, 2024, NEOTRACT WAS MADE AWARE BY A [PHYSICIAN], VIA A DOCMATTER DISCUSSION THREAD TITLED ¿NICKEL ALLERGY DEVELOPED POST UROLIFT. BEST WAY TO REMOVE ALL IMPLANTS?¿, THAT ¿[PHYSICIAN] HELPED TREAT ONE PATIENT THAT DEVELOPED SEVERE PAIN AFTER UROLIFT. THE PATIENT HAD ALREADY UNDERGONE A TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) TO REMOVE ALL THE INNER TABS. A ROBOT EXPLORATION WAS PERFORMED, AND THE CAPSULAR TABS WERE FOUND. THE PHYSICIAN NOTED UNCERTAINTY ABOUT THE CONSISTENCY OF THIS APPROACH, AS CAPSULAR TABS DO NOT ALWAYS FULLY PENETRATE THROUGH THE CAPSULE. PREOPERATIVE GUIDANCE WAS PROVIDED BY A CT SCAN AND MRI. THE PATIENT EXPERIENCED IMMEDIATE RELIEF FROM PAIN, AFTER HAVING BEEN IGNORED FOR ONE YEAR." ADDITIONAL INFORMATION RECEIVED FROM THE PHYSICIAN ON OCTOBER 1, 2024, INDICATED THAT THE PHYSICIAN DOES NOT REMEMBER MANY DETAILS, AS THIS CASE OCCURRED SEVERAL YEARS AGO DURING HIS FELLOWSHIP, AND HE WAS NOT THE ATTENDING PHYSICIAN. THE PHYSICIAN STATED: ¿THIS POST WAS IN RESPONSE TO SOMEONE ASKING ABOUT REMOVAL TO GIVE THEM SOME INSIGHT INTO WHAT HAD BEEN DONE DURING MY TRAINING.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2568258 NEOTRACT UROLIFT SYSTEM UROLIFT SYSTEM PEW NEOTRACT, INC. UROLIFT SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention