BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPOUND W NITROFREEZE

    MDR report key: 15401487 · Received September 12, 2022

    Report

    Report Number
    1719513-2022-00841
    Event Type
    Malfunction
    Date Received
    September 12, 2022
    Report Date
    October 11, 2022
    Manufacturer
    C B FLEET CO INC
    Product Code
    GEH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    INITIAL (B)(4) 2022: THIS SERIOUS MEDICAL DEVICE INCIDENT RECEIVED VIA EMAIL REFERS TO A FEMALE CONSUMER WHO WAS ACTIVATING THE COMPOUND W NITROFREEZE FOR HER SON. UPON INITIAL ACTIVATION THE CONTENTS OF THE PRODUCT EXPELLED CAUSING THE CAP TO FLY OFF...NARROWLY MISSED HITTING MY SON IN THE FACE. THREE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION (15-AUG-2022, 17-AUG-2022, 22-AUG-2022) WITH NO RESPONSE FROM THE CONSUMER. MEDDRA VERSION 25.0. EXPECTEDNESS: DEVICE PHYSICAL PROPERTY ISSUE. ACCORDING TO THE COMPANY REFERENCE SAFETY INFORMATION.

    Description of Event or Problem · 0

    INITIAL (14-AUG-2022): THIS SERIOUS MEDICAL DEVICE INCIDENT RECEIVED VIA EMAIL REFERS TO A FEMALE CONSUMER WHO WAS ACTIVATING THE COMPOUND W NITROFREEZE FOR HER SON. UPON INITIAL ACTIVATION THE CONTENTS OF THE PRODUCT EXPELLED CAUSING THE CAP TO "FLY OFF...NARROWLY MISSED HITTING MY SON IN THE FACE." THREE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION (15-AUG-2022, 17-AUG-2022, 22-AUG-2022) WITH NO RESPONSE FROM THE CONSUMER. MEDDRA VERSION 25.0. EXPECTEDNESS: DEVICE PHYSICAL PROPERTY ISSUE. ACCORDING TO THE COMPANY REFERENCE SAFETY INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1360500 COMPOUND W NITROFREEZE CRYOSURGICAL UNIT GEH C B FLEET CO INC 2131522B01(INVALID)

    Patients

    Seq Age Sex Outcome Treatment
    1 Female