BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALLEYLAB

    MDR report key: 23464213 · Received November 4, 2025

    Report

    Report Number
    1717344-2025-01427
    Event Type
    Malfunction
    Date Received
    November 4, 2025
    Report Date
    November 17, 2025
    Manufacturer
    COVIDIEN
    Product Code
    GEI
    UDI-DI
    10884524000077
    PMA / PMN Number
    K822572
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCT: E7507, E7507 POLYHESIVE II REM RET EL W/CORD (LOT#251500024T); E7507-DB, E7507-DB POLYHESIVE II REM RET EL W/CORD (LOT#UNKNOWN); E7507, E7507 POLYHESIVE II REM RET EL W/CORD (LOT#251500024T) ADDITIONAL INFORMATION: B5, D3(STREET 1, MFR CITY AND MFR REGION), D4(MODEL NUMBER, CATALOG NUMBER, EXPIRATION DATE, LOT NUMBER AND UDI), G3, H4 CORRECTION: H6(RFR <(>&<)> FDP CODING) MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3. INFORMATION RECEIVED SHOWS THAT THIS EVENT IS A DUPLICATE OF ANOTHER ISSUE REPORTED UNDER REGULATORY REPORT #: 1717344-2025-01434. THIS FILE WILL BE CLOSED AND ALL FURTHER UPDATES PROCESSED UNDER THE ABOVE-REFERENCED REPORT FOR THIS EVENT. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCT: E7507-DB, E7507-DB POLYHESIVE II REM RET EL W/CORD (LOT#UNKNOWN); E7507-DB, E7507-DB POLYHESIVE II REM RET EL W/CORD (LOT#UNKNOWN); E7507, E7507 POLYHESIVE II REM RET EL W/CORD (LOT#251500024T). MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER THE PROCEDURE, THE PATIENT EXPERIENCED SKIN PEELING THAT WAS CONSIDERED A BURN AFTER USING THE PAD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER THE PROCEDURE, THE PATIENT EXPERIENCED SKIN PEELING THAT WAS CONSIDERED A BURN AFTER USING THE PAD. THERE WAS A BLACK CIRCULAR SPOT FOUND IN ONE OF THE PAD AS SHOWN IN THE PICTURES PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2546375 VALLEYLAB ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN E7507 251810287T 10884524000077

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown PLEASE SEE NOTE ON H11