BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROCKET MEDICAL EMBRYON ECHOCATH TRIAL TRANSFER

    MDR report key: 22004950 · Received May 12, 2025

    Report

    Report Number
    MW5170224
    Event Type
    Injury
    Date Received
    May 12, 2025
    Date of Event
    May 1, 2025
    Report Date
    May 5, 2025
    Manufacturer
    ROCKET MEDICAL PLC
    Product Code
    MQF
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2025, PATIENT NOTICED A SMALL PIECE OF METAL CAME OUT OF VAGINA. IT WAS A SMALL BAND (ECHOTIP) OF ROCKET CATHETER THAT IS NEAR THE END OF THE INNER CATHETER ON BOTH THE TRIAL TRANSFER CATHETER AND THE EMBRYO TRANSFER CATHETER WHICH RETAINED UNINTENDED IN THE INTERNAL FEMALE GENITALIA ON (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1967811 ROCKET MEDICAL EMBRYON ECHOCATH TRIAL TRANSFER CATHETER, ASSISTED REPRODUCTION MQF ROCKET MEDICAL PLC R57631-EC-23 503187

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other