BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIA PROCEDURE KIT

    MDR report key: 18817561 · Received March 1, 2024

    Report

    Report Number
    1528319-2024-00015
    Event Type
    Malfunction
    Date Received
    March 1, 2024
    Date of Event
    January 30, 2024
    Report Date
    March 1, 2024
    Manufacturer
    UNITED STATES ENDOSCOPY GROUP, INC.
    Product Code
    NWU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE USER FACILITY BELIEVED THE EMPLOYEE OBTAINED THE RASH DUE TO LATEX WITHIN THE VIA PROCEDURE KIT. STERIS CONFIRMED THE PRODUCTS IN THE KIT DO NOT HAVE LATEX. DUE TO NO MALFUNCTION OR LATEX PRESENT, THE KIT WAS NOT RETURNED FOR INVESTIGATION. THIS IS THE ONLY REPORTED COMPLAINT REGARDING THIS ISSUE FOR THE VIA PROCEDURE KIT AND IS CONSIDERED AN ISOLATED EVENT. NO FURTHER INVESTIGATION IS REQUIRED. NO OTHER ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT AN EMPLOYEE NOTICED A RASH ON THEIR ARM WHILE USING A VIA PROCEDURE KIT. THE USER FACILITY DID NOT DISCLOSE IF MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1919807 VIA PROCEDURE KIT PROCEDURE KIT NWU UNITED STATES ENDOSCOPY GROUP, INC. 00717380

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown