BEUDAMED
    FDA Adverse Event Summary report: N

    CRYOTIP

    MDR report key: 5412835 · Received February 3, 2016

    Report

    Report Number
    2022379-2016-00001
    Date Received
    February 3, 2016
    Date of Event
    December 10, 2015
    Report Date
    February 2, 2016
    Manufacturer
    IRVINE SCIENTIFIC SALES CO., INC.
    Product Code
    MQH
    PMA / PMN Number
    K041562
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE END USER, CUSTOMER, REPORTED TO THE IRVINE SCIENTIFIC TECHNICAL APPLICATION SCIENTIST THE EVENT THAT OCCURRED ON (B)(6) 2015 WHEN THE EMBRYOS WERE THAWED. TECHNICAL APPLICATION SCIENTIST WAS CONTACTED BY THE END USER ON 01/04/2016. ADDITIONAL DEVICE: LOT # 40709, CATALOG # IST-067A, DATE OF MANUFACTURE 02/23/2012, EXPIRY DATE 05/30/2014. (B)(6). LOSS OF CELLS (HUMAN EMBRYOS). UNABLE TO ENTER DEVICE CODE MQH, MICROTOOLS, ASSISTED REPRODUCTION (PIPETTES). END USER REPORTED THAT THE MEDICAL DEVICE, CRYOTIP, CRACKED DURING THE THAWING PROCESS AND THE PATIENT EMBRYOS WERE NOT RECOVERED. THE MEDICAL DEVICE WAS DISCARDED BY THE END USER FOLLOWING THE EVENT THAT OCCURRED ON (B)(6) 2015 AND WAS REPORTED TO THE TECHNICAL APPLICATION SCIENTIST ON 01/04/2016. THE MEDICAL DEVICE WAS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER FOR INVESTIGATION AS IT WAS DISCARDED AFTER THAWING. THE TECHNICAL APPLICATION SPECIALIST, AN EMPLOYEE OF IRVINE SCIENTIFIC, WAS CONTACTED BY THE CUSTOMER, END USER, ON 01/04/2016 REGARDING THE THAWING OF THE MEDICAL DEVICE, CRYOTIP, THAT OCCURRED ON (B)(6) 2015. THE TECHNICAL APPLICATION SPECIALIST SPOKE WITH THE END USER TO CON FIRM THAT THEY HAD BEEN TRAINED IN THE USE OF THE CRYOTIP AS PART OF THE INVESTIGATION. IRVINE SCIENTIFIC SALES CO., INC. IS FILING THIS MDR WITH AN ABUNDANCE OF CAUTION. THIS MDR SUBMISSION IS OUR INITIAL AND FINAL REPORT. A FOLLOW UP REPORT WILL NOT BE SUBMITTED.

    Description of Event or Problem · 1

    THE END USER REPORTED THAT THE MEDICAL DEVICE, CRYOTIP, CONTAINING HUMAN EMBRYOS CRACKED DURING THE THAWING PROCESS AND THE PATIENT EMBRYOS WERE NOT RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66728 CRYOTIP CRYOTIP MQH IRVINE SCIENTIFIC SALES CO., INC. 40709

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other