BEUDAMED
    FDA Adverse Event Other Summary report: N

    CRYOTIP

    MDR report key: 2963589 · Received December 3, 2012

    Report

    Report Number
    2022379-2012-00002
    Event Type
    Other
    Date Received
    December 3, 2012
    Date of Event
    June 4, 2012
    Report Date
    November 29, 2012
    Manufacturer
    IRVINE SCIENTIFIC
    Product Code
    MQH
    PMA / PMN Number
    K041562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY DID NOT REPORT THE EVENT TO IRVINE SCIENTIFIC. IRVINE SCIENTIFIC WAS MADE AWARE OF THE EVENT UPON RECEIPT OF THE MEDWATCH FORM FDA 3500A FROM THE FDA FOR THE EVENT. THE MEDWATCH FORM PROVIDED DOES NOT PROVIDE ANY ADDITIONAL INFORMATION WITH REGARDS TO THE DEVICE OR THE DEVICE LOT NUMBER FOR AN INVESTIGATION TO BE PERFORMED. DETAILS WITH REGARDS TO THE PRODUCT LOT NUMBER HAVE NOT BEEN PROVIDED.

    Description of Event or Problem · 1

    IRVINE SCIENTIFIC RECEIVED A MEDWATCH FORM FDA 3500A FROM THE FDA FOR A USER FACILITY THAT REPORTED THE EVENT UNDER REPORT (B)(4). THE EVENT REPORTED WAS THAT A CRYOPRESERVATION LOOP FAILED ("EXPLODED"), CAUSING EMBRYOS TO MELT AND LOSE VIABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYOTIP CRYOTIP MQH IRVINE SCIENTIFIC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR