BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CANNULA 10CM 10MM TIP 18G SHARP CURVED

    MDR report key: 7549404 · Received May 29, 2018

    Report

    Report Number
    3006630150-2018-01884
    Event Type
    Injury
    Date Received
    May 29, 2018
    Date of Event
    May 4, 2018
    Report Date
    May 29, 2018
    Manufacturer
    COSMAN MEDICAL
    Product Code
    GXI
    UDI-DI
    00813250012101
    PMA / PMN Number
    K060799
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED: MODEL #: RFK-C101018S, LOT #: M607, DESCRIPTION: RFK CANNULA, 10CM; 10MM ACTIVE TIP, SHARP, CURVED,18G QUANTITY: 4, MODEL #: CSK-10, LOT #: F138, DESCRIPTION: CSK-10 KIT INCLUDES: 1EA. CSK 100MM TC ELECTRODE, 1EA. CB112-TC CABLE, 1EA. STERILIZING CASE QUANTITY: 2 MODEL #: CSK-10 LOT #: I243 DESCRIPTION: CSK-10 KIT INCLUDES: 1EA. CSK 100MM TC ELECTRODE, 1EA. CB112-TC CABLE, 1EA. STERILIZING CASE QUANTITY: 1 MODEL #: CSK-10 LOT #: L535 DESCRIPTION: CSK-10 KIT INCLUDES: 1EA. CSK 100MM TC ELECTRODE, 1EA. CB112-TC CABLE, 1EA. STERILIZING CASE QUANTITY: 1 IT IS INDICATED THAT THE DEVICES WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORDS WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MED WATCH WILL BE FILED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT ONE WEEK FOLLOWING AN RF ABLATION PROCEDURE, A PATIENT EXPERIENCED 8 SKIN TAGS ON HIS BACK AT THE INSERTION SITE OF THE NEEDLES. THE PHYSICIAN ASSESSED THAT THE PATIENT EXPERIENCED AN ALLERGIC REACTION, IT IS UNKNOWN IF TREATMENT WAS PROVIDED FOR THE SYMPTOMS. AN ALLERGY TEST WAS PERFORMED BUT THE RESULTS WILL NOT BE PROVIDED. THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391324 CANNULA 10CM 10MM TIP 18G SHARP CURVED PROBE, RADIOFREQUENCY LESION GXI COSMAN MEDICAL RFK-C101018S M607 00813250012101

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention