BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARTER KIT, SIZE 2, 1212

    MDR report key: 88665 · Received May 2, 1997

    Report

    Report Number
    1224675-1997-00029
    Event Type
    Injury
    Date Received
    May 2, 1997
    Date of Event
    April 3, 1997
    Report Date
    April 21, 1997
    Manufacturer
    UROMED CORP.
    Product Code
    MNG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PATIENT REPORTED WHEN REMOVING THE DEVICE THE STRING CAME OUT WITH THE DEFLATED BALLOON ON THE END, HOWEVER SHE COULD NOT GRASP THE REST OF THE INSERT TO REMOVE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARTER KIT, SIZE 2, 1212 RELIANCE MNG UROMED CORP. SIZE 2 0000000007

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention