BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITIND, WITH SNARE, STERILE

    MDR report key: 21044404 · Received December 30, 2024

    Report

    Report Number
    2429304-2024-01063
    Event Type
    Injury
    Date Received
    December 30, 2024
    Date of Event
    November 23, 2024
    Report Date
    December 30, 2024
    Manufacturer
    MEDI-TATE LTD.
    Product Code
    QKA
    UDI-DI
    07290015518062
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THE FOLLOWING DAY AFTER A BPH (BENIGN PROSTATIC HYPERPLASIA) TREATMENT PROCEDURE, THE PATIENT COMPLAINED OF EXCESSIVE LEAKING OF URINE. IT WAS FOUND OUT THAT THIS IMPLANTABLE SUBJECT DEVICE HAD MIGRATED. A MEDICAL INTERVENTION WAS DONE TO ANCHOR THE SUBJECT DEVICE AGAIN WITH NO SUCCESS. THE SUBJECT DEVICE WAS REMOVED, AND IT WAS FOUND THE ANCHORING LEAF SEEMED DEFECTIVE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN OLYMPUS BACK UP DEVICE. THERE WERE NO FURTHER REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2419087 ITIND, WITH SNARE, STERILE WA2ITA00 QKA MEDI-TATE LTD. WA2ITA00 NI 07290015518062

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention