BEUDAMED
    FDA Adverse Event Death Summary report: N

    *

    MDR report key: 1495680 · Received September 9, 2009

    Report

    Report Number
    1495680
    Event Type
    Death
    Date Received
    September 9, 2009
    Date of Event
    May 5, 2009
    Report Date
    September 9, 2009
    Manufacturer
    ALCO INDUSTRIES
    Product Code
    KSD
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    HUMAN EMBRYOS BEING PREPPED FOR FREEZE. TIPS OF STRAWS CONTAINING EMBRYOS WERE HEAT SEALED AND THEN FROZEN. DURING THAW IT WAS FOUND THAT THE STRAWS WERE EMPTY OF THE CONTENTS.

    Description of Event or Problem · 1

    HUMAN EMBRYOS BEING PREPPED FOR FREEZE. TIPS OF STRAWS CONTAINING EMBRYOS WERE HEAT SEALED AND THEN FROZEN. DURING THAW IT WAS FOUND THAT THE STRAWS WERE EMPTY OF THE CONTENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * HEAT SEALER KSD ALCO INDUSTRIES * *
    2 CRYOTIP STRAWS EMBRYO PRESERVATION OOF IRVINE SCIENTIFIC * T-025A, T-018A, T022A

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death