BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRYOTIP

    MDR report key: 2814294 · Received October 8, 2012

    Report

    Report Number
    2814294
    Event Type
    Malfunction
    Date Received
    October 8, 2012
    Date of Event
    June 21, 2012
    Report Date
    October 8, 2012
    Manufacturer
    IRVINE SCIENTIFIC
    Product Code
    MQH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CRYOPRESERVATION LOOP USED FOR IVF FAILED ("EXPLODED"), CAUSING THE EMBRYOS TO MELT AND THEREFORE LOSE VIABILITY.

    Description of Event or Problem · 1

    CRYOPRESERVATION LOOP USED FOR IVF FAILED ("EXPLODED"), CAUSING THE EMBRYOS TO MELT AND THEREFORE LOOSE VIABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYOTIP MICROTOOL, ASSISTED REPRODUCTION MQH IRVINE SCIENTIFIC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR