BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUM

    MDR report key: 21183533 · Received January 17, 2025

    Report

    Report Number
    3018382913-2025-00001
    Event Type
    Malfunction
    Date Received
    January 17, 2025
    Date of Event
    October 21, 2024
    Report Date
    January 17, 2025
    Manufacturer
    623 MEDICAL
    Product Code
    MLY
    PMA / PMN Number
    K202782
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 12/20/2024, A FOLLOW UP CALL WAS MADE TO THE FACILITY WHERE THE EVENT OCCURRED. KENDRA SCHULZ, VASCULAR ACCESS RN MANAGER AT THE(B)(6) CONFIRMED THAT THEY RECEIVED PHOTOS FROM THE PATIENT AND NOTED "THE RED AREA WAS OBVIOUSLY A SQUARE, THE SAME SIZE AS A TEGADERM...IN THE PICTURES THE PATIENT PROVIDED YOU COULD ALSO SEE THE POKE MARK AT THE BOTTOM OF THE RECTANGLE, WHICH IS ANOTHER REASON IT HAD TO DO MORE WITH THE TEGADERM THAN THE NUM SPRAY". TEGADERM IS A TRANSPARENT, STERILE, PLASTIC DRESSING MANUFACTURED BY 3M USED FOR IV CATHETER SITE DRESSINGS. THE CENTER CONCLUDED THAT THE PATIENT HAD A REACTION TO THE MEDICAL ADHESIVE ON THE TEGADERM, AND THUS DID NOT NOTIFY 623 MEDICAL OF THE EVENTS. THE SITE IS NOT ABLE TO SHARE THE PATIENT PICTURES WITH 623 MEDICAL. THE SITE CONFIRMED THAT THEY HAVE HAD NO REPORTS OF OTHER ISSUES WITH NÜM. THE NUM IFU 11026-370-09 REV B INSTRUCTS HEALTHCARE PROVIDERS TO "HOLD THE CONTAINER WITH NOZZLE POINTED OVER THE TREATMENT AREA APPROXIMATELY 3 TO 6 INCHES AWAY FROM THE APPLICATION SITE. PRESS THE ACTUATOR BUTTON FIRMLY WITH THUMB, ALLOWING NÜM TO SPRAY FROM THE CONTAINER FOR 4-6 SECONDS UNTIL THE SKIN JUST TURNS WHITE." SPECIFICALLY FOR NUMBING APPLICATION PRE-INJECTION, THE INSTRUCTIONS FOR USE ARE AS FOLLOWS "PREPARE THE SYRINGE AND SWAB THE TREATMENT AREA WITH AN ANTISEPTIC PER STANDARD PROCEDURE. SPRAY THE TREATMENT AREA WITH NÜM CONTINUOUSLY FOR 4 TO 6 SECONDS FROM 3 TO 6 INCHES AWAY FROM THE SITE UNTIL THE SKIN JUST TURNS WHITE. DO NOT FROST THE SKIN/AREA. AVOID SPRAYING BEYOND THE TARGET AREA. WITH THE SKIN TAUT, QUICKLY INTRODUCE THE NEEDLE. REAPPLY AS NEEDED. FOLLOW THESE DIRECTIONS FOR OTHER TYPES OF NEEDLE INSERTION PROCEDURES SUCH AS STARTING IV'S AND VENIPUNCTURE." USERS ARE PRECAUTIONED THAT THE "THAWING PROCESS MAY BE PAINFUL", "EXCESSIVE USE MAY ALTER SKIN PIGMENTATION" AND "FREEZING MAY LOWER LOCAL RESISTANCE TO INFECTION AND DELAY HEALING". NO LOT NUMBER WAS REPORTED, THUS A REVIEW OF THE LOT RECORD COULD NOT BE PERFORMED. THIS REPORT OR OTHER INFORMATION SUBMITTED BY (623 MEDICAL) UNDER 21 CFR PART 803, AND ANY RELEASE BY FDA OF THAT REPORT OR INFORMATION, DOES NOT REFLECT A CONCLUSION BY 623 MEDICAL OR FDA THAT THE REPORT OR INFORMATION CONSTITUTES AN ADMISSION THAT THE DEVICE, 623 MEDICAL, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.

    Description of Event or Problem · 0

    ON 11/27/2024, FDA HAD INITIALLY SENT MW5162011 TO GEBAUER. ON 12/20/2024, 623 MEDICAL RECEIVED AN ENVELOPE FROM GEBAUER CO THAT CONTAINED MW5162011. THE VOLUTARY MEDWATCH SUBMITTED BY THE PATIENT INCORRECTLY IDENTIFIED THE MEDICAL DEVICE AS PAIN EASE ON THE MEDWATCH FORM. HOWEVER, THE "DESCRIBE EVENT OR PROBLEM" SECTION OF THE MEDWATCH FORM CORRECTLY IDENTIFIED THE NUM DEVICE. THIS IS THE DESCRIPTION OF THE EVENT AS STATED ON MW5162011: GETTING READY FOR CTA CAT SCAN OF MY HEART, NEEDED NUMB SPRAY ON ARM TO NUMB ME BEFORE IV PLACED, NURSE USED NUM AKA PAIN EASE HOWEVER, THIS NUM I BELIEVE WAS MADE IN A CHILD'S PACKAGING MANNER BECAUSE THIS TINY LITTLE CONTAINER IS A WHITE AND BLUE BEAR OVER RESEARCHING I FIND IT IS THE SAME THING AS PAIN IS JUST IN A CHILD FRIENDLY PACKAGING MADE BY THE COMPANY GEBAUER. THE NURSE SPRAYED ME QUICK THEN PROCEEDED TO PLACE THE IV WHICH SHE WAS UNSUCCESSFUL. SHE CALLED THE IV TEAM DOWN. MAN CAME DOWN WITH HIS ULTRASOUND MACHINE FOUND THE VAN CLOSE TO THE FIRST VAN IN MY ARM THAT THE NURSE TRIED TO DO HE HAD HIS OWN BOTTLE, THE LITTLE WHITE BEAR AND I TOLD HIM AGAIN THAT I AM A NEEDLE FOB, SO HE PULLED OUT HIS LITTLE BEAR AND HE EMPTIED THE ENTIRE BOTTLE ON MY ARM SO NOW IT WAS SPRAYED BY THE NURSE QUICKLY THEN THE IV TEAM COMES DOWN AND SPRAYS ME AGAIN BUT EMPTIES THE ENTIRE CONTAINER OF REFRIGERANT WITH 24 TO 36 HOURS I HAVE A BURN ON MY ARM I ALERTED THE (B)(6) WHERE I HAD THE CAT SCAN A THAT THIS HAD HAPPENED TO ME AND THEY'RE GOING TO WANT TO RETURN THEIR PEOPLE AS TO NOT OVERDOSE ON THIS STUFF BECAUSE IT IS A REFRIGERANT IT WILL CAUSE FROSTBITE. THIS IS DOCUMENTED OVER AND OVER WITH THESE CHEMICALS ON THE INTERNET TO RESEARCH AND ORGANIZATIONS THAT IF YOU APPLY THESE FREE SPRAYS FOR TOO LONG, YOU WILL GET FROSTBITE BUT WHICH INTERN TURNS INTO A BURN AND THAT'S EXACTLY WHAT I HAVE AND I DID LET THE UNIVERSITY OF MINNESOTA KNOW HOWEVER THEY'RE NOT VERY INTERESTED IN GETTING BACK TO ME EVEN THOUGH I SAID I WAS BURNED YOU THINK THEY WOULD JUMP AT THE OPPORTUNITY TO CAL ME RIGHT AWAY GET THE FULL STORY. WHO DID I WORK WITH? HOW CAN THEY LEARN FROM THIS BUT OF COURSE THEY DIDN'T BECAUSE THEY'RE NOT A VERY GOOD (B)(6) HERE IN (B)(6) THIS MORNING IS (B)6) I WENT TO MY LOCAL URGENT CARE AND RIGHT AWAY THE DOCTOR SAID I WAS HAVING ALLERGIC REACTION ACTER I EXPLAINED HOW IT HAPPENED. IT IS DEFINITELY NOT AN ALLERGIC REACTION. I'VE HAD "PAIN EASE" IN THE ADULT FORM BEFORE I HAVE PICTURES OF IT THAT I TOOK AT A DIFFERENT HOSPITAL WHEN I HAD AN ANGIOGRAM THE IV PERSON USED IT, I WAS VERY IMPRESSED THAT IT WORKED SO I TOOK A PICTURE OF THIS CAN HOWEVER THEY DID NOT DUMP WHOLE CAN ON ME OF COURSE IT WAS AN ADULT SIZE CAN ALL IT WAS A QUICK SPRAY THAT'S IT JUST LIKE THE NURSE GAVE ME A SPRAY AND TRIED TO IV AND SHE COULDN'T ON MONDAY FOR MY CTA SO I FIND OUT THIS LITTLE BEAR. THIS LITTLE WHITE CANISTER. BEAR IS THE SAME THING, BUT LIKE I SAID, MORE CHILD, FRIENDLY IN THE SHAPE OF A BEAR SINGLE USE ITEM SO THE IV GUY COMES DOWN, DUMPS THE WHOLE CANISTER ON MY ARM WHERE IT ALREADY BEEN SPRAYED NOW I'M BURNED, ABOUT 24-36 HOURS LATER, IT STARTED TO APPEAR. IT HAS REMAINED ITS SAME COLOR SAME SHAPE SAME SIZE SINCE THAT TIME WHICH WOULD'VE BEEN ABOUT MAYBE I NOTICED ON MONDAY 24-36 HOURS LATER AND IT IS DEFINITELY NOT A RASH AND LIKE I SAID, I'VE USED PAIN EASE BEFORE NEVER HAD A PROBLEM HOWEVER, IF YOU OVERDOSE IN APPLYING IT ON AN ARM OR ON THE BODY IF YOU PUT TOO MUCH YOU'RE GONNA FREEZE IT AND BURN THE SKIN AND THAT'S EXACTLY WHAT HAS HAPPENED TO ME OVERUSED ON ME. IT IS NOT A RASH LIKE I JUST WENT TO THE DOCTOR TO PROVE THIS EVEN FURTHER I'M NOT GOING TO URGENT CARE. I'M GOING TO A DERMATOLOGIST OR BURN DOCTOR AND I'M GONNA SAY WHAT DOES THIS LOOK LIKE BURN/ RASH NEED SOMEBODY KNOWLEDGEABLE TO CONFIRM BECAUSE I'M NOT GONNA LET THIS PRODUCT HURT ME AND I'M GONNA MAKE SURE THE (B)(6) HERE IN (B)(6) KNOWS WHAT HAS HAPPENED TO ME AGAIN A SECOND TIME SO THAT THEY CAN TRAIN THEIR PEOPLE NOT TO JUST SPRAY PEOPLE/ KIDS DOWN WITH THIS UNTIL THEY GET A BURN BUT THAT SWIPE SEEMS TO BE QUITE SUFFICIENT DUMPING THIS WHOLE ENTIRE BEAR SMALL CHILD LIKE CANISTER OF [?]NUM' MADE BY THE SAME COMP WHO MAKES PAIN EASE THAT I SPOKE ABOUT ABOVE WITH THE EXACT SAME CHEMICALS JUST ANY DIFFERENT PACKAGE MORE CHILD FRIENDLY SO YES, YOU CAN GET BURNED BUY THESE PRODUCTS REFRIGERANTS YOU WILL GET FROSTBITE/ BURNED. THE U DOESN'T CARE THANKS (B)(6). NOTE REDACTION (B)(6) INDICATES INFORMATION WITHHELD TO MAINTAIN PERSONAL PRIVACY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1016770 NUM VAPOCOOLANT MLY 623 MEDICAL NS01B UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other