BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RF CANNULA

    MDR report key: 6592718 · Received May 25, 2017

    Report

    Report Number
    3006630150-2017-01950
    Event Type
    Injury
    Date Received
    May 25, 2017
    Date of Event
    May 5, 2017
    Report Date
    May 5, 2017
    Manufacturer
    COSMAN MEDICAL
    Product Code
    GXI
    PMA / PMN Number
    K060799
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION STATED THAT NO FURTHER INFORMATION COULD BE OBTAINED REGARDING THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4), LOT I757 RFK CANNULA 100MM, 5MM TIP, 20G, SHARP, CURVED 10/PK. THE RETURNED CANNULA EXHIBITS NORMAL DEVICE CHARACTERISTICS. REVIEW OF THE DEVICE HISTORY/ PACKAGING/ STERILIZATION DHR REVEALED NO ANOMALIES.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT FOLLOWING A PROCEDURE, THE PATIENT EXPERIENCED AN ALLERGIC REACTION AT THE LOCATION WHERE THE CANNULA WAS INSERTED. IT IS NOT KNOWN IF ANY TREATMENT WAS PROVIDED AT THIS TIME.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT FOLLOWING A PROCEDURE, THE PATIENT EXPERIENCED AN ALLERGIC REACTION AT THE LOCATION WHERE THE CANNULA WAS INSERTED. IT IS NOT KNOWN IF ANY TREATMENT WAS PROVIDED AT THIS TIME.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT FOLLOWING A PROCEDURE, THE PATIENT EXPERIENCED AN ALLERGIC REACTION AT THE LOCATION WHERE THE CANNULA WAS INSERTED. IT IS NOT KNOWN IF ANY TREATMENT WAS PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371871 RF CANNULA CANNULA GXI COSMAN MEDICAL RFK-C10520S-P I757

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention