BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDICOM DURAFLOR HALO 5% SODIUM FLOURIDE VARNISH

    MDR report key: 11455741 · Received March 10, 2021

    Report

    Report Number
    9611959-2021-00001
    Event Type
    Injury
    Date Received
    March 10, 2021
    Date of Event
    January 28, 2021
    Report Date
    June 30, 2021
    Product Code
    LBH
    PMA / PMN Number
    K040098
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION IS IN PROGRESS. THIS COMPLAINT IS CAPTURED UNDER AMD MEDICOM INC. COMPLAINT NUMBER (B)(4). FOLLOW-UP INFORMATION: AN INVESTIGATION WAS CONDUCTED AND CONFIRMED THAT THERE ARE NO TREE NUTS IN THE PRODUCT 1015-WB32 (DHVARNISH5% FLUORIDE WILDBERRY). THE LABELLING INDICATES NOT TO USE THE PRODUCT WITH A KNOW ALLERGY OR REACTION TO COLOPHONY (COLOPHONIUM). COLOPHONIUM IS A TERM USED FOR TREE RESIN (ROSIN). THE ROSIN IS EXTRACTED FROM PINE TREES BUT DOES NOT CONTAIN TREE NUTS. THE MANUFACTURER STATED THAT T THEY ARE NOT AN ALLERGEN FREE FACILITY, HOWEVER, THERE IS NO PHYSICAL CONTACT BETWEEN PRODUCTS AND THAT A CLEANING PROCEDURE IS UNDERTAKEN BETWEEN BATCHES AND PRODUCTS TO AVOID CROSS CONTAMINATION. A PROBABLE CAUSE IS THAT THE PATIENT HAS AN ALLERGY TO COLOPHONIUM. NO LABELING CHANGES ARE REQUIRED BASED ON THIS INCIDENT. THE DENTAL PROFESSIONAL, IN THEIR OWN WORDS, SAW THE STATEMENT ON THE BOX REGARDING CONTRAINDICATION TO "COLOPHONIUM" BEFORE APPLICATION AND PROCEEDED TO APPLY THE VARNISH ANYWAY. THEREFORE, A BETTER ALERT WOULD NOT HAVE PREVENTED THIS EVENT AS THE ALERT WAS IGNORED AS IN THE ORIGINAL REPORT FROM THE DENTIST "I REMEMBERED SOMETHING ABOUT TREE NUT ALLERGIES AND VARNISH SO I GRABBED THE BOX OF HALO VARNISH TO READ AND IT VERY SPECIFICALLY STATES NO NUTS, DAIRY, ETC. THE ONLY CONTRAINDICATION IS AN ALLERGY TO "COLOPHONIUM". WHO EVEN KNOWS WHAT THAT IS? I PLACED THE VARNISH."

    Description of Event or Problem · 0

    THE FOLLOWING WAS RECEIVED BY AMD MEDICOM: "ON (B)(6) 2021 I HAD A 7 YEAR OLD PATIENT IN MY CHAIR FOR AN EXAM. SHE NOTED AN ALLERGY TO SEVERAL ITEMS INCLUDING TREE NUTS. I REMEMBERED SOMETHING ABOUT TREE NUT ALLERGIES AND VARNISH SO I GRABBED THE BOX OF HALO VARNISH TO READ AND IT VERY SPECIFICALLY STATES NO NUTS, DAIRY, ETC. THE ONLY CONTRAINDICATION IS AN ALLERGY TO "COLOPHONIUM". WHO EVEN KNOWS WHAT THAT IS? I PLACED THE VARNISH. THIS LITTLE GIRL ENDED UP IN THE ER WITH ANAPHYLAXIS. SHE IS LUCKILY OK. LOOKING INTO THIS FURTHER, COLOPHONIUM IS A SYNTHETIC RESIN MADE FROM TREES. IF THERE HAD BEEN A MORE OBVIOUS ALERT, THIS COULD HAVE BEEN AVOIDED. IMAGINE IF SHE HAD DIED? THIS IS A REAL POSSIBILITY. THERE NEEDS TO BE A MORE OBVIOUS ALERT ON THIS BOX! " "ROUGHLY 20 MINUTES AFTER APPLICATION, PATIENT GOT HIVES ON MOUTH AND THROAT SWELLING. PATIENT REQUIRED EMERGENCY DEPARTMENT INTERVENTION FOR ANAPHYLAXIS AND HIVES. THERE NEEDS TO BE A MUCH BETTER ALERT ON THE BOX. NO ONE KNOWS WHAT "COLOPHONIUM" IS. "

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS IN PROGRESS. THIS COMPLAINT IS CAPTURED UNDER AMD MEDICOM INC. COMPLAINT NUMBER (B)(4).

    Description of Event or Problem · 1

    THE FOLLOWING WAS RECEIVED BY AMD MEDICOM: "ON (B)(6) 2021 I HAD A (B)(6) YEAR OLD PATIENT IN MY CHAIR FOR AN EXAM. SHE NOTED AN ALLERGY TO SEVERAL ITEMS INCLUDING TREE NUTS. I REMEMBERED SOMETHING ABOUT TREE NUT ALLERGIES AND VARNISH SO I GRABBED THE BOX OF HALO VARNISH TO READ AND IT VERY SPECIFICALLY STATES NO NUTS, DAIRY, ETC. THE ONLY CONTRAINDICATION IS AN ALLERGY TO "COLOPHONIUM". WHO EVEN KNOWS WHAT THAT IS? I PLACED THE VARNISH. THIS LITTLE GIRL ENDED UP IN THE ER WITH ANAPHYLAXIS. SHE IS LUCKILY OK. LOOKING INTO THIS FURTHER, COLOPHONIUM IS A SYNTHETIC RESIN MADE FROM TREES. IF THERE HAD BEEN A MORE OBVIOUS ALERT, THIS COULD HAVE BEEN AVOIDED. IMAGINE IF SHE HAD DIED? THIS IS A REAL POSSIBILITY. THERE NEEDS TO BE A MORE OBVIOUS ALERT ON THIS BOX! " "ROUGHLY 20 MINUTES AFTER APPLICATION, PATIENT GOT HIVES ON MOUTH AND THROAT SWELLING. PATIENT REQUIRED EMERGENCY DEPARTMENT INTERVENTION FOR ANAPHYLAXIS AND HIVES. THERE NEEDS TO BE A MUCH BETTER ALERT ON THE BOX. NO ONE KNOWS WHAT "COLOPHONIUM" IS. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353584 MEDICOM DURAFLOR HALO 5% SODIUM FLOURIDE VARNISH VARNISH LBH

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Life Threatening| O| R