BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NÜM

    MDR report key: 24594995 · Received March 13, 2026

    Report

    Report Number
    3018382913-2026-00001
    Event Type
    Injury
    Date Received
    March 13, 2026
    Date of Event
    February 13, 2026
    Report Date
    March 11, 2026
    Manufacturer
    623 MEDICAL
    Product Code
    MLY
    PMA / PMN Number
    K202782
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THROUGH ADDITIONAL CONTACT WITH THE CENTER, NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THE FOUR IDENTIFIED LOTS WILL UNDERGO TESTING. NÜM VAPOCOOLANT IS A BLENDED GAS WHERE 1,1,1,2-TETRAFLUOROETHANE (HFC134A) IS THE ACTIVE INGREDIENT. THE 623 MEDICAL CLINICAL CONSULTANT, MD, PROVIDED THE FOLLOWING STATEMENT, "THE STERILE VAPOCOOLANT USED IN NÜM CONTAINS HYDROFLUOROCARBON HFC-134A (1,1,1,2-TETRAFLUOROETHANE), THE SAME VAPOCOOLANT USED IN OTHER PRODUCTS SUCH AS GEBAUER'S PAIN-EASE. THE PRIMARY DISTINCTION IS THAT NÜM IS SUPPLIED AS A STERILE, SINGLE-DOSE APPLICATOR. FROM A PHYSICAL STANDPOINT, HFC-134A VAPOR IS APPROXIMATELY FOUR TO FIVE TIMES HEAVIER THAN ROOM AIR AND DISPERSES DOWNWARD AND OUTWARD RAPIDLY AFTER SPRAYING. THE COMPOUND BOILS AT ROOM TEMPERATURE AND VOLATILIZES IMMEDIATELY UPON RELEASE, MEANING IT DOES NOT PERSIST ON THE SKIN AS A LIQUID. HFC-134A IS CHEMICALLY INERT AND, BASED ON ITS MOLECULAR STRUCTURE, IS NOT CAPABLE OF ACTING AS AN ANTIGEN THAT WOULD TRIGGER IGE-MEDIATED ALLERGY, URTICARIA, OR ANAPHYLAXIS. VAPOCOOLANTS CONTAINING HFC-134A HAVE BEEN USED IN CLINICAL PRACTICE FOR SEVERAL DECADES. PUBLISHED CLINICAL STUDIES EVALUATING VAPOCOOLANT SPRAYS FOR PROCEDURES SUCH AS IV CANNULATION HAVE CONSISTENTLY REPORTED NO SERIOUS SYSTEMIC ADVERSE EFFECTS; THE MINOR EFFECTS OCCASIONALLY DESCRIBED INCLUDE TRANSIENT COLD SENSATION, BRIEF DISCOMFORT, OR MILD LOCAL ERYTHEMA. SYMPTOMS SUCH AS DIZZINESS, CHEST DISCOMFORT, OR SHORTNESS OF BREATH CAN HAVE MULTIPLE POTENTIAL CAUSES AND ARE NOT COMMONLY REPORTED WITH THE ROUTINE CLINICAL USE OF HFC-134A VAPOCOOLANTS. IN THE BROADER TOXICOLOGY LITERATURE, THESE TYPES OF SYMPTOMS HAVE BEEN DESCRIBED PRIMARILY IN THE CONTEXT OF SUBSTANTIAL INHALATIONAL EXPOSURE TO FLUOROCARBON REFRIGERANTS (FOR EXAMPLE, REFRIGERANT LEAKS, CONFINED-SPACE OCCUPATIONAL EXPOSURE, OR INTENTIONAL INHALATION ABUSE), WHICH REPRESENTS A MARKEDLY DIFFERENT EXPOSURE SCENARIO THAN BRIEF TOPICAL MEDICAL APPLICATION. EVEN IN THOSE SETTINGS, REPORTED EFFECTS ARE TYPICALLY TRANSIENT AND NON-TOXIC AT LOWER EXPOSURE LEVELS. NÜM HAS BEEN USED IN A VARIETY OF CLINICAL SETTINGS FOR SEVERAL YEARS WITHOUT REPORTS OF TOPICAL OR INHALATIONAL ADVERSE REACTIONS. IN THE PUBLISHED LITERATURE, REPORTED REACTIONS ASSOCIATED WITH MODERN HFC-BASED VAPOCOOLANTS USED IN CLINICAL PRACTICE APPEAR TO BE EXTREMELY RARE."

    Description of Event or Problem · 0

    ON 13FEB2026, 623 MEDICAL WAS NOTIFIED OF A POSSIBLE ALLERGIC REACTION A NURSE AT (B)(6) HOSPITAL MAY HAVE EXPERIENCED AFTER USING THE NÜM SPRAY. 623 MEDICAL FOLLOWED UP WITH THE CENTER 13FEB, 17 FEB, AND 18FEB2026 AND RECEIVED THE FOLLOWING INFORMATION VIA EMAIL 18FEB2026, RN AT THE CENTER REPORTED THE FOLLOWING, "THE NURSE I CALLED AN RRT (RAPID RESPONSE TEAM) ON HAD SOB (SHORTNESS OF BREATH) RIGHT AFTER USING THE SPRAY. SHE SAID HER CHEST STARTED TO HURT, SHE BEGAN GETTING SWEATY, AND BY ABOUT 30 MIN SHE GOT REALLY SOB AND STARTED TO COLLAPSE TO THE FLOOR GETTING DIZZY. WE PLACED HER ON OXYGEN AND SENT HER TO ED (EMERGENCY DEPARTMENT). THEY ENDED UP LEAVING HER ON OXYGEN AND MONITORING HER FOR A FEW HOURS BUT SENT HER HOME. SHE SAID AT HOME SHE STILL HAD CHEST PAIN AND SOB BUT RESOLVED BY THE NEXT DAY." NO ADDITIONAL INFORMATION WAS PROVIDED BY CENTER. THIS HOSPITAL SYSTEM IS CONDUCTING AN INTERNAL INVESTIGATION (THIS MAY INCLUDE ENVIRONMENTAL, EXPOSURE, OR OTHER FACTORS) AND HAS NOT PROVIDED ANY ADDITIONAL INFORMATION TO 623 MEDICAL AT THE TIME OF THIS REPORT. FOUR LOTS WERE DISTRIBUTED TO THE CENTER: LOTS 1104, 1105, 1106, AND 1245. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED FROM OTHER DEPARTMENTS OF THE SAME HOSPITAL SYSTEM. ADDITIONALLY, NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED FROM OTHER CUSTOMERS REGARDING THESE LOTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659915 NÜM NÜM VAPOCOOLANT MLY 623 MEDICAL NS01B

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other