BEUDAMED
    FDA Adverse Event Injury Summary report: N

    US RELIANCE SIZE/PK UNK

    MDR report key: 88659 · Received May 2, 1997

    Report

    Report Number
    1224675-1997-00028
    Event Type
    Injury
    Date Received
    May 2, 1997
    Date of Event
    April 17, 1997
    Report Date
    April 21, 1997
    Manufacturer
    UROMED CORP.
    Product Code
    MNG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD DEVICE MIGRATE INTO HER BLADDER, UPON REMOVAL OF THE DEVICE, THE "FLANGE" WAS MISSING.

    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 Required Intervention