BEUDAMED
    FDA Adverse Event Other Summary report: N

    COOK CHORIONIC VILLUS SAMPLING SET

    MDR report key: 232576 · Received July 14, 1999

    Report

    Report Number
    1825146-1999-00011
    Event Type
    Other
    Date Received
    July 14, 1999
    Date of Event
    February 22, 1999
    Report Date
    July 14, 1999
    Manufacturer
    COOK OB/GYN
    Product Code
    LLX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PREGNANCY OUTCOME FORM STATES THAT OROMADIBULAR/LIMB DYSTROPHY HAD OCCURRED, THE CHILD IS MISSING THE LEFT HAND. A FOLLOW UP LETTER FROM THE FACILITY STATES THAT THE PT HAD A CVS PROCEDURE USING A COOK CVS SET ON 08-12-98 AND SUBSEQUENTLY GAVE BIRTH TO A CHILD WITH A TERMINAL TRANSVERSE LIMB ANOMALY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOK CHORIONIC VILLUS SAMPLING SET SAMPLING DEVICE LLX COOK OB/GYN NA 457029

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DAY Congenital Anomaly