BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEOTRACT UROLIFT 2 SYSTEM

    MDR report key: 20518629 · Received October 23, 2024

    Report

    Report Number
    3015181082-2024-00029
    Event Type
    Injury
    Date Received
    October 23, 2024
    Date of Event
    July 1, 2024
    Report Date
    November 21, 2024
    Manufacturer
    NEOTRACT, INC.
    Product Code
    PEW
    UDI-DI
    10814932020343
    PMA / PMN Number
    K201837
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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 OCTOBER 7, 2024, NEOTRACT HAS BEEN MADE AWARE THAT ¿A PATIENT REQUIRED MULTIPLE PROCEDURES AND SEVERAL ER VISITS. THE PROCEDURE WAS STANDARD, WITH FOUR IMPLANTS PLACED IN THE CORRECT LOCATIONS. THE PATIENT LATER PRESENTED TO THE ER WITH URINARY RETENTION AND SUBSEQUENTLY RETURNED WITH A HEMATOMA. THE PATIENT WAS TREATED WITH A PAE (PROSTATIC ARTERY EMBOLIZATION) AND HAD TO UNDERGO SURGERY DUE TO CONTINUED BLEEDING." ADDITIONAL INFORMATION RECEIVED ON OCTOBER 22, 2024, INDICATED THAT A NEOTRACT REPRESENTATIVE WAS INFORMED OF THE EVENT ON (B)(6) 2024. THE UROLIFT PROCEDURE WAS PERFORMED IN JULY, EXACT DATE WAS NOT PROVIDED. TWO DAYS POST-PROCEDURE, THE PATIENT DEVELOPED A PELVIC HEMATOMA. ON THE FIRST NIGHT FOLLOWING THE PROCEDURE, THE PATIENT RETURNED TO THE EMERGENCY ROOM DUE TO URINARY RETENTION AND WAS CATHETERIZED. THE NEXT NIGHT, THE PATIENT WAS READMITTED WITH A SEVERE PELVIC HEMATOMA. TREATMENT INCLUDED PROSTATIC ARTERY EMBOLIZATION (PAE), AN OPEN LAPAROTOMY, AND A BLOOD TRANSFUSION. THE PATIENT¿S CURRENT CONDITION IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1424753 NEOTRACT UROLIFT 2 SYSTEM UROLIFT 2 SYSTEM PEW NEOTRACT, INC. UROLIFT 2 SYSTEM 10814932020343

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention