BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARTER KIT, SIZE 1, 1211

    MDR report key: 94678 · Received May 27, 1997

    Report

    Report Number
    1224675-1997-00035
    Event Type
    Injury
    Date Received
    May 27, 1997
    Date of Event
    May 13, 1997
    Report Date
    May 16, 1997
    Manufacturer
    UROMED CORP.
    Product Code
    MNG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT REPORTED INSERTING THE DEVICE AND "IT WENT UP INSIDE" AND SHE COULDN'T FIND IT. ON 5/15/97 PT WAS SEEN BY A MEDICAL PROFESSIONAL. AN EXAMINATION WAS DONE BY THE MEDICAL PROFESSIONAL WITH NO DEVICE FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARTER KIT, SIZE 1, 1211 RELIANCE MNG UROMED CORP. SIZE 1 0000000006

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention