BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITIND, WITH SNARE, STERILE

    MDR report key: 20493451 · Received October 21, 2024

    Report

    Report Number
    2429304-2024-0000446
    Event Type
    Injury
    Date Received
    October 21, 2024
    Date of Event
    August 8, 2024
    Report Date
    October 21, 2024
    Manufacturer
    MEDI-TATE, LTD
    Product Code
    QKA
    UDI-DI
    07290015518062
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE ATTEMPTING TO REMOVE THE ITIND, THE SUTURE BECAME DETACHED FROM THE HUB. THE REMOVAL PROCEDURE WAS NOT PERFORMED UNDER ANESTHESIA, ONLY A LOCAL TOPICAL GEL. THE PROCEDURE TOOK ROUGHLY TWO HOURS AND THE PATIENT EXPERIENCED "ADDITIONAL TRAUMA" TO THE URETHRA FROM MULTIPLE REMOVAL ATTEMPTS. A CYSTOSCOPE WAS ULTIMATELY REQUIRED, IN ADDITION TO GRASPING FORCEPS, TO REMOVE THE DEVICE. NO OTHER MEDICAL INTERVENTION WAS REQUIRED. FOLLOWING THE PROCEDURE, THERE WERE NO OTHER INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1011736 ITIND, WITH SNARE, STERILE WA2ITA00 QKA MEDI-TATE, LTD WA2ITA00 28112022-1 07290015518062

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention