BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIFNECK SELECT EXTRICATION COLLAR

    MDR report key: 19794076 · Received July 22, 2024

    Report

    Report Number
    3004993040-2024-00001
    Event Type
    Injury
    Date Received
    July 22, 2024
    Date of Event
    June 24, 2024
    Report Date
    July 24, 2024
    Manufacturer
    LAERDAL MEDICAL AS
    Product Code
    IQK
    UDI-DI
    07045430049307
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION HAS BEEN COMPLETED AND THE FULL ANALAYSIS PROVIDED BELOW (PROVISIONAL ANALYSIS PREVIOUSLY PROVIDED). ADVERSE EVENT PROBLEM CODES IN H6 (A AND D) HAVE BEEN CORRECTED. INVESTIGATION ANALYSIS: AS THIS CUSTOMER COMPLAINT HAS GOOD, DETAILED INFORMATION IT IS FAIR TO ASSUME THAT THE ALLERGIC REACTION CAN BE RELATED BACK TO THE STIFNECK SELECT. THE CUSTOMER HAS EXPERIENCED IT ON 5 DIFFERENT OCCASIONS WITH DIFFERENT DEVICES. THE CUSTOMER HAS NOT HAD A NEED FOR HOSPITAL ADMISSION, BUT HAS HAD TO TAKE MEDICATION TO TREAT THE ALLERGIC REACTION. THE DESCRIBED SYMPTOMS INDICATE MOSTLY A LOCAL RESPONSE DUE TO THE LACK OF NEED FOR HOSPITALIZATION. WE HAVE REVIEWED THE RISK TRACEABILITY MATRIX FOR STIFNECK SELECT (00050291 REV D) AND UNDER RISK-026 IT IS DESCRIBED THE MITIGATION OF HAVING PATIENT CONTACT MATERIAL IN COMPLIANCE WITH ISO-10993. VERIFICATION REFERENCE IS TO THE BIOLOGICAL SAFETY EVALUATION (00064802 REV E) WHERE THE FOAM FOR THE STIFNECK HAS A GAP IN BIOCOMPATIBILITY DOCUMENTATION. THE FOAM WAS TESTED FOR BIOCOMPATIBILITY IN 2004/2005. THE FOLLOWING DISCUSSION IS INCLUDED IN THE REPORT: "THE FOAM COMPONENTS (WHITE AND DARK) FOR NECKBAND AND CHIN SUPPORT OF THE STIFNECK ARE IN CONTACT WITH THE INTACT SKIN OF THE PATIENT'S NECK AND JAW. THE POLYETHYLENE FOAM MATERIALS WERE TESTED FOR CYTOTOXICITY, IRRITATION, AND SENSITIZATION AT THE SOOCHOW UNIVERSITY LAB IN (B)(6), CHINA IN 2004/2005. THE TESTS PASSED, INDICATING A LOW BIOLOGICAL SAFETY RISK FOR THESE MATERIALS IN PATIENT CONTACT. HOWEVER, THE APPLIED TEST METHODS FOR IRRITATION AND SENSITIZATION TESTING INVOLVED EXTRACTION USING SALINE ONLY, THE EXTRACTIONS WERE THEREFORE NOT PERFORMED IN ACCORDANCE WITH THE CURRENT ISO 10993-12:2021 [8] NOR WITH THE VERSION OF THE SUBSTANDARD AT THE TIME OF TESTING IN 2006. BIOLOGICAL TESTING IN ACCORDANCE WITH CURRENT REGULATORY REQUIREMENTS WOULD IMPLY EXTRACTING THE DEVICE IN BOTH A POLAR (TYPICALLY WATER) AND A NON-POLAR SOLVENT (TYPICALLY VEGETABLE OIL). THE EXTRACTION PARAMETERS (TEMPERATURE/TIME) APPLIED FOR TESTING OF THE WHITE AND DARK FOAM FOR SENSITIZATION AND IRRITATION DEVIATES. MORE STRINGENT PARAMETERS WERE APPLIED FOR THE WHITE FOAM THAN FOR THE DARK. LAERDAL HAS A CHANGE CONTROL AGREEMENT IN PLACE WITH THE FOAM MATERIAL MANUFACTURER, PREVENTING THE MANUFACTURER OF MAKING ANY CHANGES IN THE MATERIAL COMPOSITION OR MANUFACTURING PROCESS. FURTHER, POLYETHYLENE IS IN GENERAL CONSIDERED TO BE A MATERIAL WITH FEW CONCERNS FROM A BIOLOGICAL SAFETY PERSPECTIVE." THE CONCLUSION SUMMARIZES: "THERE ARE GAPS IN THE BIOCOMPATIBILITY DOCUMENTATION FOR THE WHITE AND DARK FOAM MATERIAL USED FOR BOTH STIFNECK EXTRICATION COLLARS AND THE STIFNECK SELECT COLLARS. STILL, CONSIDERING THE INTENDED USE AND THAT THE COLLARS ARE IN PATIENT CONTACT FOR A LIMITED TIME (< 24 HOURS) THE BIOLOGICAL RISK FOR THE PATIENT RELATED TO THESE GAPS IN DOCUMENTATION AND TESTING ARE EVALUATED TO BE LOW. THE LONG-TIME USE OF THESE FOAM MATERIALS LAERDAL MEDICAL DEVICES WITHOUT CUSTOMER COMPLAINTS OR OTHER REPORTS THAT MAY BE RELATED TO THE BIOLOGICAL SAFETY OF THE MATERIALS, SUPPORT THAT THE MATERIALS ARE SAFE AND DO NOT CAUSE ADVERSE DERMAL REACTIONS SUCH AS IRRITATION OR SENSITIZATION." THIS CUSTOMER COMPLAINT IS THE FIRST CUSTOMER COMPLAINT OF ITS TYPE. THE DEVICE HAS BEEN ON THE MARKET FOR OVER 15 YEARS AND INSTALLED BASE OF THE LAST 5 YEARS IS, AS OF (B)(6) 2024, (B)(4) DEVICES. SALES ARE APPROXIMATELY (B)(4). THE RISKS OF BIOCOMPATIBILITY IS AS MENTIONED COVERED IN OUR RISK MANAGEMENT FILE WITH A POTENTIAL OCCURRENCE OF EXTREMELY UNLIKELY ((B)(4)). THIS EVENT DOES NOT CHANGE THE POTENTIAL OCCURRENCE. EVEN SO, A RISK REVIEW WITH FOCUS ON THE FOAM IS RECOMMENDED FOR AN INTERNAL DISCUSSION.

    Additional Manufacturer Narrative · 0

    LAERDAL HAS PERFORMED AN INTERNAL INVESTIGATION. THE USER HAS GIVEN GOOD, DETAILED INFORMATION SO IT IS FAIR TO ASSUME THAT THE ALLERGIC REACTION CAN BE RELATED BACK TO THE STIFNECK SELECT. THE USER THINKS ITS LIKELY THAT IT IS RELATED TO THE FOAM PADDING ON THE STIFNECK SELECT, AND ROOT CAUSE OF THIS INCIDENT HAS BEEN IDENTIFIED AS AN ALLERGIC REACTION MOST LIKELY FROM THE FOAM ON STIFNECK SELECT. THE RISK OF PATIENT CONTACTING MATERIAL NOT BEING BIOCOMPATIBLE IS EVALUATED AS RISK-026 IN THE RISK TRACEABILITY MATRIX (00050291 REV D). THE IDENTIFIED MITIGATION IS THAT PATIENT CONTACTING MATERIAL SHALL BE IN ACCORDANCE WITH ISO 10993. LAERDALS' BIOLOGICAL SAFETY EVALUATION (00064802 REV E) IDENTIFIES A GAP IN BIOCOMPATIBILITY DOCUMENTATION FOR STIFNECK SELECT. THIS GAP WAS EVALUATED AS PART OF THE BENEFIT/RISK RATIO OF THE DEVICE, AND WITH CONSIDERATION TO THE INTENDED USE, THE SHORT TIME THE STIFNECK SELECT IS APPLIED TO A PERSON, AND THE LONG HISTORY OF THE DEVICE IN MARKET WITH NO PREVIOUS CUSTOMER COMPLAINTS OR OTHER REPORTS THAT MAY BE RELATED TO THE BIOLOGICAL SAFETY OF THE MATERIALS, LAERDAL EVALUATES THAT THE MATERIALS ARE SAFE AND DO NOT CAUSE ADVERSE DERMAL REACTIONS SUCH AS IRRITATION OR SENSITIZATION. THIS REPORTED INCIDENT IS NEW INFORMATION REGARDING THIS TOPIC, BUT AS THE DEVICE HAS BEEN ON THE MARKET FOR OVER 15 YEARS WITH NO SIMILAR KNOWN INCIDENTS, THE RISK OCCURRENCE IS UNCHANGED. DUE TO THIS NEW INFORMATION REGARDING BIOCOMPATIBILITY, LAERDAL WILL PERFORM A RISK REVIEW.

    Description of Event or Problem · 0

    ON THE 24TH JUNE 2024 A USER WHO WORKS AS A HEALTH CARE PROFESSIONAL REPORTED AN INCIDENT THAT HAPPENED AT (B)(6) (USA). THE USER HAD AN ALLERGIC REACTION WHILE USING A STIFNECK SELECT EXTRICATION COLLAR ON A PATIENT. HE REPORTED: "I HAD A PATIENT WHO REQUIRED A C-COLLAR AFTER A ROLL OVER. I WAS AT THE HEAD OF THE PATIENT TO TRANSFER HIM FROM OUR GURNEY TO THE HOSPITAL BED. DURING THAT TRANSFER IS WHEN THE WHITE FOAM ABOVE THE BLUE PLASTIC PIECE TOUCHED MY LEFT FOREARM ABOVE THE GLOVE LINE. TEN MINUTES AFTER EXPOSURE I STARTED TO FEEL MY LEFT BECOMING HOT AND ITCHY. I NOTICED A SMALL RED CIRCLE ON MY FOREARM. THIRTY MINUTES PASTED BEFORE I WAS ABLE TO TAKE A OVER THE COUNTER ALLERGY MEDICATION ZYRTEC. IT WAS ABLE TO STOP MY ARMS FROM ITCHING FOR ONLY ABOUT TEN MINUTES. ONCE THE ZYRTEC STOPPED WORKING I STARTED TO UTICARIA FORM ON BOTH ARMS AND I FELT LIKE THERE WAS "GOLF BALL" WAS IN MY THROAT. MY PARTNER WAS ABLE TO TREAT ME WITH EPINEPHRINE DUE TO ME GOING INTO ANAPHYLAXIS. I WAS TREATED WITH EPINEPHRINE. IT STOPPED MY ANAPHYLACTIC REACTION I WAS ABLE TO RETURN TO WORK WITHOUT ISSUES. THIS WAS MY 5TH EXPOSURE TO THE STIFNECK C-COLLARS. THIS WAS MY FIRST ANAPHYLACTIC REACTION JUST FROM A SIGNAL TOUCH." NO HOSPITALIZATION WAS REQUIRED FOR THE USER. THE USER REPORTED THAT HIS HEALTH WAS "NORMAL" ON THE DAY OF THE INCIDENT. THE USER REPORTED THAT THE PATIENT BEING TREATED WITH COLLAR HAD NO REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2221299 STIFNECK SELECT EXTRICATION COLLAR CERVICAL SPINE COLLAR, SINGLE-USE IQK LAERDAL MEDICAL AS 4523 07045430049307

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Male Other