BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUFREEZE

    MDR report key: 4936025 · Received July 23, 2015

    Report

    Report Number
    3010140265-2015-00006
    Event Type
    Injury
    Date Received
    July 23, 2015
    Date of Event
    May 30, 2015
    Report Date
    July 22, 2015
    Manufacturer
    CSA MEDICAL
    Product Code
    GEH
    PMA / PMN Number
    K150920
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    MALE PATIENT RECEIVED SPRAY CRYOTHERAPY TREATMENT (SCT) ON (B)(6) 2015. THE NIGHT OF (B)(6) 2015 THE PATIENT DEVELOPED RUQ ABDOMINAL PAIN. THE NEXT DAY, (B)(6) 2015, THE PAIN BECAME MORE SEVERE AND RADIATED TO HIS LOWER ABDOMEN, PROMPTING HIM TO GO TO THE ER. HE WAS HOSPITALIZED FOR 13 DAYS AND DURING THAT TIME BLOOD WORK SHOWED ELEVATED AMYLASE, LIPASE, AND A CT SCAN POSITIVE FOR ACUTE PANCREATITIS. PATIENT DOES NOT HAVE GALL STONES NOR A HISTORY OF ETHANOL ABUSE. FINAL DIAGNOSIS WAS IDIOPATHIC PANCREATITIS. THE RELATIONSHIP OF SCT AND PANCREATITIS IS HIGHLY UNLIKELY. HOWEVER, A POSSIBLE CAUSAL RELATIONSHIP WITH THE DEVICE COULD NOT BE RULED OUT BECAUSE OF THE TEMPORAL ASSOCIATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478238 TRUFREEZE UNIT, CRYOSURGICAL, ACCESSORIES GEH CSA MEDICAL CC3-01

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R