BEUDAMED
    FDA Adverse Event Other Summary report: N

    CRYOTIP

    MDR report key: 2625838 · Received June 11, 2012

    Report

    Report Number
    2022379-2012-00001
    Event Type
    Other
    Date Received
    June 11, 2012
    Date of Event
    May 7, 2012
    Report Date
    June 11, 2012
    Manufacturer
    IRVINE SCIENTIFIC
    Product Code
    MQH
    PMA / PMN Number
    K041562
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS NOT CLEAR FROM THE LITTLE INFO THAT HAS BEEN PROVIDED BY THE USER IF A SERIOUS INJURY OCCURRED. IRVINE SCIENTIFIC WILL FILE A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION. CUSTOMER IS LOCATED IN (B)(6) AND REPORTED TO IRVINE SCIENTIFIC'S DISTRIBUTOR IN (B)(4) THAT AN END USER OBTAINED A "LITTLE LACERATION" ON HIS FACE WHEN THAWING SPECIMENS CONTAINED IN THE DEVICE. DETAILS WITH REGARDS TO THE PRODUCT LOT NUMBER AND A DESCRIPTION OF THE INJURY HAVE NOT BEEN PROVIDED AFTER SEVERAL REQUESTS. IRVINE SCIENTIFIC HAS DILIGENTLY REQUESTED DETAILS WITH REGARDS TO THE INJURY THAT WAS SUSTAINED AND THE PRODUCT SPECIFIC LOT NUMBER AND HAD NOT BEEN SUCCESSFUL AND IS FILING THIS REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    CUSTOMER IS LOCATED IN CHINA AND REPORTED TO THE IRVINE SCIENTIFIC'S DISTRIBUTOR IN CHINA THAT AN END USER OBTAINED A "LITTLE LACERATION" ON HIS FACE WHEN THAWING SPECIMENS CONTAINED IN THE DEVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other