BEUDAMED
    FDA Adverse Event Other Summary report: N

    ELECTRODE REM PLYHESIVE ADULT GROUNDING PAD

    MDR report key: 19404793 · Received May 24, 2024

    Report

    Report Number
    MW5155397
    Event Type
    Other
    Date Received
    May 24, 2024
    Date of Event
    May 20, 2024
    Report Date
    May 23, 2024
    Manufacturer
    COVIDIEN
    Product Code
    GEI
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    REM POLYHESIVE ADULT PATIENT RETURN ELECTRODE BY COVIDIEN VALLEY LAB (REF # E7507). LOT 240640162T EXPIRATION DATE 2026-02-28 FAILED X4 TIMES WITH EACH ELECTRODE. ANOTHER ELECTRODE FROM A DIFFERENT LOT OBTAINED AND WORKED. DIAGNOSIS FOR USE: ENDOSCOPY PROCEDURE. REFERENCE REPORTS: MW5155395, MW5155396, MW5155398.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1940031 ELECTRODE REM PLYHESIVE ADULT GROUNDING PAD ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN E7507 240640162

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female