BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMBRYON ECHOCATH TRIAL

    MDR report key: 14375606 · Received May 11, 2022

    Report

    Report Number
    MW5109653
    Event Type
    Malfunction
    Date Received
    May 11, 2022
    Date of Event
    March 21, 2022
    Report Date
    May 9, 2022
    Manufacturer
    ROCKET MEDICAL PLC
    Product Code
    MQF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ECHO BAND FELL OFF X 1 AND REMAINED IN THE PATIENT'S VAGINA POST PROCEDURE, OBJECT WAS PASSED NATURALLY. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2504710 EMBRYON ECHOCATH TRIAL CATHETER, ASSISTED REPRODUCTION MQF ROCKET MEDICAL PLC 495856

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Female