BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARTER KIT, SIZE 4, 1214

    MDR report key: 97610 · Received June 10, 1997

    Report

    Report Number
    1224675-1997-00039
    Event Type
    Injury
    Date Received
    June 10, 1997
    Date of Event
    May 12, 1997
    Report Date
    June 6, 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

    PT REPORTED INSERTING DEVICE INTO HER VAGINA. MD REMOVED. NO SERIOUS INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARTER KIT, SIZE 4, 1214 RELIANCE MNG UROMED CORP. SIZE 4 0000000009

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention