BEUDAMED
    FDA Adverse Event Summary report: N

    CRYOTIP

    MDR report key: 4272012 · Received November 18, 2014

    Report

    Report Number
    2022379-2014-00002
    Date Received
    November 18, 2014
    Report Date
    November 18, 2014
    Manufacturer
    IRVINE SCIENTIFIC
    Product Code
    MQH
    PMA / PMN Number
    K041562
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY, (B)(6), DID NOT REPORT THE EVENT TO IRVINE SCIENTIFIC. THE PT CALLED ON (B)(6) 2014 STATING SHE WAS AN EMPLOYEE OF (B)(6) AND WANTED TO DISCUSS THE CRYOTIP ON BEHALF OF A CLIENT WHOM SHE STATED LOST EMBRYOS DUE TO MICROFRACTURES. (B)(6) CONFIRMED THE INDIVIDUAL WAS NOT AN EMPLOYEE AND WAS THEIR PT, AND CONFIRMED THAT THEY DID NOT HAVE AN EVENT TO REPORT WITH REGARDS TO THIS PT. (B)(6) CONFIRMED THAT THE PT HAD BEEN TO SEVERAL FERTILITY CLINICS AND HAS NOT BECOME PREGNANT AND HAS QUESTIONED THE PROCEDURES THAT HAVE BEEN PERFORMED DURING THE COURSE OR HER TREATMENT. (B)(6) CONFIRMED THAT THEY DID NOT PROVIDE ANY DETAILS TO THE PT WITH REGARDS TO THE USE OF THE CRYOTIP. (B)(6) DID NOT PROVIDE ANY DETAILS REGARDING THE PRODUCT LOT NUMBER OF THE CRYOTIP TO IRVINE SCIENTIFIC. BASED UPON OUR INVESTIGATION IRVINE SCIENTIFIC WAS NOT ABLE TO CONFIRM THE OCCURRENCE OF THE EVENT REPORTED BY THE PT WHEN SHE CALLED POSING AS A (B)(6) EMPLOYEE.

    Description of Event or Problem · 1

    IRVINE SCIENTIFIC RECEIVED A CALL FROM THE ABOVE MENTIONED PT, ON (B)(6) 2014. THE PT FIRST STATED SHE WAS THE CUSTOMER SERVICE REP AND LATER IN THE CALL STATED SHE WAS THE RECEPTIONIST CALLING ON BEHALF OF THE PT FROM (B)(6). THE PT REPORTED SHE WANTED TO DISCUSS THE CRYOTIP AS A CLIENT OF HERS HAD LOST EMBRYOS DUE TO MICROFRACTURES. (B)(6) INFORMED IRVINE SCIENTIFIC THAT THE ABOVE MENTIONED PT WAS NOT AN EMPLOYEE OF THEIR FACILITY AND WAS IN FACT THEIR PT. IRVINE SCIENTIFIC FOLLOWED UP WITH (B)(6), AND THEY DID NOT HAVE ANY ADDITIONAL INFO TO PROVIDE AS THEY DID NOT RECORD AN EVENT REGARDING MICROFRACTURES USING THE CRYOTIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744353 CRYOTIP CRYOTIP MQH IRVINE SCIENTIFIC NR NR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other