BEUDAMED
    FDA Adverse Event Injury Summary report: N

    US RELIANCE SIZE/PK UNK

    MDR report key: 91344 · Received May 13, 1997

    Report

    Report Number
    1224675-1997-00031
    Event Type
    Injury
    Date Received
    May 13, 1997
    Date of Event
    April 30, 1997
    Report Date
    May 1, 1997
    Manufacturer
    UROMED CORP.
    Product Code
    MNG
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PATIENT REPORTED INSERTING A DEVICE INTO HER VAGINA. PATIENT WENT TO LOCAL MEDICAL CLINIC WHERE A MEDICAL PROFESSIONAL WAS ABLE TO REMOVE THE DEVICE WITH AN INSTRUMENT AND WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 US RELIANCE SIZE/PK UNK RELIANCE MNG UROMED CORP. * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN