BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE GROUNDING PAD W/CABLE

    MDR report key: 24544952 · Received March 9, 2026

    Report

    Report Number
    3005334138-2026-00131
    Event Type
    Injury
    Date Received
    March 9, 2026
    Date of Event
    February 11, 2026
    Report Date
    May 1, 2026
    Manufacturer
    ABBOTT MEDICAL (AFD-PLYMOUTH)
    Product Code
    GEI
    PMA / PMN Number
    K111576
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. BASED ON THE INFORMATION RECEIVED, A SINGLE DEFINITIVE ROOT CAUSE FOR THE ISSUE ENCOUNTERED WAS UNABLE TO BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING AN RFA ABLATION ON (B)(6) 2026 THE PATIENT FELT A BURNING SENSATION AT THE GROUNDING PAD SITE. AFTER THE PAD WAS REMOVED THE PATIENT HAD TWO SMALL BURNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2843 DISPOSABLE GROUNDING PAD W/CABLE RFA GROUNDING PAD GEI ABBOTT MEDICAL (AFD-PLYMOUTH) RF-DGP-S 20241105

    Patients

    Seq Age Sex Outcome Treatment
    1