BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN RAPID RHINO TECHNOLOGY DEV

    MDR report key: 22373837 · Received July 1, 2025

    Report

    Report Number
    3006524618-2025-00336
    Event Type
    Injury
    Date Received
    July 1, 2025
    Report Date
    July 1, 2025
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    EMX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE (B)(4). H11 H3, H6: THIS COMPLAINT WAS OPENED BY SMITH+NEPHEW TO DOCUMENT A PATIENT COMPLICATION IDENTIFIED THROUGH A REVIEW OF CLINICAL EVIDENCE FROM LITERATURE SOURCES THAT INCLUDES REFERENCE TO THE USE OF A SMITH+NEPHEW PRODUCT. THE REPORTED ISSUE(S) RELATE TO KNOWN INHERENT PROCEDURAL RISKS THAT ARE APPROPRIATELY DOCUMENTED IN OUR RISK FILES. SMITH+NEPHEW WILL CONTINUE TO MONITOR TRENDS IN ACCORDANCE WITH OUR POST-MARKET SURVEILLANCE PROCESS AND TAKE NECESSARY ACTION AS REQUIRED IF ANTICIPATED SEVERITY AND/OR OCCURRENCE RATES ARE EXCEEDED. SMITH+NEPHEW HAS NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY SPECIFICATIONS AT THE TIME OF MANUFACTURE. BASED ON OUR REVIEW OF ALL CURRENTLY AVAILABLE INFORMATION, WE ARE UNABLE TO CONFIRM A RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE DEVICE OR IDENTIFY A DEFINITIVE ROOT CAUSE. HOWEVER, AS THE USE OF OUR PRODUCT CANNOT BE EXCLUDED AS A POTENTIAL CAUSE OR CONTRIBUTORY FACTOR TO THE REPORTED ISSUE, WE ARE CONSERVATIVELY SUBMITTING THIS REPORT IN ACCORDANCE WITH APPLICABLE REGULATIONS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THAT ALTERS THE CONCLUSIONS OF THIS REPORT, A FOLLOW-UP REPORT WILL BE SUBMITTED AS REQUIRED. ARTICLE: OH, J. T., & BAE, M. R. (2023). RISK FACTORS FOR REBLEEDING AFTER SUCCESSFUL RAPID RHINO PACKING IN EPISTAXIS PATIENTS. JOURNAL OF RHINOLOGY, 30(1), 23-30.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON LITERATURE REVIEW "RISK FACTORS FOR REBLEEDING AFTER SUCCESSFUL RAPID RHINO PACKING IN EPISTAXIS PATIENTS", 43 PATIENTS HAD REBLEEDING AFTER A EPISTAXIS EPISODE WHERE A RAPID RHINO DEVICE WAS USED. 41 PATIENTS REQUIRED ELECTROCAUTERY AND 2 PATIENTS REQUIRED CHEMOCAUTERIZATION WITH ALBOTHYL(POLICRESULEN SOLUTION). PATIENTS OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1262064 UNKN RAPID RHINO TECHNOLOGY DEV BALLOON, EPISTAXIS EMX ARTHROCARE CORPORATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O