BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARTER KIT, SIZE 3, 1213

    MDR report key: 86851 · Received April 21, 1997

    Report

    Report Number
    1224675-1997-00025
    Event Type
    Injury
    Date Received
    April 21, 1997
    Date of Event
    March 27, 1997
    Report Date
    April 14, 1997
    Manufacturer
    UROMED CORP.
    Product Code
    MNG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PT REPORTED DEVICE PARTIALLY MIGRATED INTO HER URETHRA, SHE WAS ABLE TO REMOVE THE DEVICE BUT THERE WAS BLOOD ON DEVICE AFTER REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARTER KIT, SIZE 3, 1213 RELIANCE MNG UROMED CORP. SIZE 3 0000000008

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention