BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIZE 3, 50 PACK (ASTRA)

    MDR report key: 115338 · Received August 22, 1997

    Report

    Report Number
    1224675-1997-00045
    Event Type
    Injury
    Date Received
    August 22, 1997
    Date of Event
    July 4, 1997
    Report Date
    August 15, 1997
    Manufacturer
    UROMED CORP.
    Product Code
    MNG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PT REPORTED DEVICE INCORRECTLY INSERTED INTO VAGINA. WHILE TRYING TO REMOVE THE DEVICE, THE STRING BROKE AND PT COULD NOT RETRIEVE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIZE 3, 50 PACK (ASTRA) URINARY CONTROL INSERT MNG UROMED CORP. SIZE 3 M96B030

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention