BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOSENSE WEBSTER NGEN

    MDR report key: 17071303 · Received June 6, 2023

    Report

    Report Number
    MW5118180
    Event Type
    Injury
    Date Received
    June 6, 2023
    Date of Event
    March 29, 2023
    Report Date
    June 5, 2023
    Manufacturer
    BIOSENSE WEBSTER INC.
    Product Code
    OAE
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    AT TIME OF DISCHARGE, NOTED THAT PATIENT HAD WHAT APPEARED TO BE A SUPERFICIAL BURN. PATIENT REPORTED FOLLOW UP WITH PROVIDER AND NOTED A THIRD DEGREE BURN AT THE DOCUMENTED SITE. AFTER REVIEW, IT WAS IDENTIFIED THAT THE SUPERFICIAL BURN AT THE TIME OF DISCHARGE WAS LOCATED IN THE SAME PLACE AS THE GROUNDING PAD, LOWER RIGHT POSTERIOR FLANK. DURING INTERNAL INVESTIGATION, IT WAS NOTED THAT VENDOR RECOMMENDATIONS WERE DIFFERENT THAN COMMON PRACTICE, REGARDING NUMBER OF GROUNDING PADS FOR RADIOFREQUENCY GENERATOR. STANDARD FACILITY PRACTICE WAS MAINTAINED WITH TWO GROUNDING PADS IN PLACE, HOWEVER ONLY ONE GROUNDING PAD WAS PLUGGED INTO GENERATOR PER VENDOR RECOMMENDATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674833 BIOSENSE WEBSTER NGEN CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE BIOSENSE WEBSTER INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Required Intervention