BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDLINE UNIVERSAL STYLE GROUNDING PAD FOR ELECTROCAUTERY

    MDR report key: 17540001 · Received August 11, 2023

    Report

    Report Number
    MW5144510
    Event Type
    Injury
    Date Received
    August 11, 2023
    Date of Event
    June 15, 2023
    Report Date
    August 9, 2023
    Manufacturer
    MEDLINE INDUSTRIES, LP - NORTHFIELD
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    INITIAL GROUNDING PAD BROKE AS IT WAS REMOVED FROM PACKAGING. A SECOND GROUNDING PAD WAS APPLIED AND THE FAILED DURING SURGICAL PROCEDURE. A THIRD GROUNDING PAD WAS OPENED AND APPLIED SO PROCEDURE COULD CONTINUE. REFERENCE REPORT: MW5144509.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1707300 MEDLINE UNIVERSAL STYLE GROUNDING PAD FOR ELECTROCAUTERY ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDLINE INDUSTRIES, LP - NORTHFIELD

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Required Intervention