BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARTER KIT, SIZE 3, 1213

    MDR report key: 96241 · Received June 4, 1997

    Report

    Report Number
    1224675-1997-00038
    Event Type
    Injury
    Date Received
    June 4, 1997
    Date of Event
    May 20, 1997
    Report Date
    May 30, 1997
    Manufacturer
    UROMED CORP.
    Product Code
    MNG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PT REPORTED SHE WAS UNABLE TO FEEL OR SEE DEVICE WHEN SHE WENT TO REMOVE THE DEVICE. PT SAW A MEDICAL PROFESSIONAL FOR EXAMINATION, NO DEVICE WAS FOUND.

    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