BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GOLDSTEIN SONOHYSTEROGRAPHY CATHETER

    MDR report key: 2594645 · Received November 26, 2010

    Report

    Report Number
    2594645
    Event Type
    Injury
    Date Received
    November 26, 2010
    Date of Event
    September 23, 2010
    Report Date
    October 6, 2010
    Manufacturer
    COOK OB/GYN
    Product Code
    HFF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, PT PRESENTED FOR "SALINE INFUSION SONOHYSTEROGRAPHY" FOR EVALUATION OF INFERTILITY UTILIZING THE LISTED PRODUCT. ON (B)(6) 2010, THE PT CHECKED THE POSITION OF HER CERVIX AND NOTICED A "HARD OBJECT" AT THE CERVICAL ENTRANCE. SHE REMOVED THE OBJECT, PLACED IT IN A (B)(4) BAG AND REPORTED TO THE ER FOR EVALUATION. THE PIECE APPEARS TO BE AN "ADJUSTABLE ACORN POSITIONER" THAT HOLDS THE CATHETER IN PLACE AND PREVENTS LEAKAGE. THE ORIGINAL ITEM IS NOT AVAILABLE, BUT ANOTHER UNUSED ITEM FROM THE SAME LOT IS AVAILABLE FOR EVALUATION. THE PT SUFFERED NO ADVERSE OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GOLDSTEIN SONOHYSTEROGRAPHY CATHETER SONOHYSTEROGRAPHY CATHETER HFF COOK OB/GYN J-GSHC-532600 U1957881

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention